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A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tazarotene Foam
Vehicle Foam
Sponsored by
Stiefel, a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female age 12 through 45 years, inclusive, who is in good general health.
  • An ISGA score of 3 or greater at baseline.

  • Lesion counts meeting both of the following criteria:

    1. Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular lesion (<5mm), with NO cystic lesions.
    2. Between 30 and 125 facial noninflammatory lesions, excluding nasal lesions. - Regular menstrual cycle prior to study entry for females of childbearing potential.
  • Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses.

Women who are not currently sexually active must agree to use medically accepted method of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception.

  • Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
  • Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion Criteria:

  • Female who is pregnant, trying to become pregnant, or breast feeding.
  • Use of topical antibiotics on the face within the past 2 weeks.
  • Use of systemic antibiotics for acne treatment within the past 4 weeks.
  • Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines) because of the possibility of augmented photosensitivity.
  • Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks.
  • Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
  • Treatment with estrogens, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to study enrollment. Subjects that have been treated with these medications for more than 12 consecutive weeks prior to study enrollment are allowed to enroll as long as they do not expect to change the dose or drug, or to discontinue use during the study and it has not been indicated for the treatment of acne vulgaris.
  • Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, or salicylates) within the past 2 weeks.
  • Concomitant use of facial products such as: abradants, facials, peels containing glycolic or other acids, masks, washes or soaps.
  • Concomitant use of medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins, haloperidol, and immunosuppressants such as cyclosporine) as these may impact efficacy assessments. Multivitamins, iron supplements, and folate are acceptable.
  • Facial procedure (eg, blue light, chemical or laser peel, or microdermabrasion) within the past 4 weeks.
  • Require or desire excessive or prolonged exposure to ultraviolet light during the study.
  • Known hypersensitivity or previous allergic reaction to any of the active components of the study product.
  • A significant medical history of or currently immunocompromised.
  • Use of any investigational product within the past 4 weeks or currently participating in another clinical study.
  • Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
  • Any major illness within 30 days before study enrollment.
  • Currently lives in the same household as currently enrolled subjects; is an employee of Stiefel, an investigator, or a CRO involved in the study; or is an immediate family member (eg, partner, offspring, parents) of an employee involved in the study

Sites / Locations

  • The Laser Institute for Dermatology
  • FXM Research Corporation
  • Atlanta Dermatology & Vein Research Center, PC
  • Gwinnett Clinical Research Center, Inc.
  • Hudson Dermatology
  • Dermatology Specialists
  • Henry Ford Medical Center
  • Somerset Skin Centre
  • Skin Specialists, P.C.
  • Dermatology Associates of Rochester, PC
  • Clinical Partners, LLC
  • Suzanne Bruce and Associates, PA
  • Progressive Clinical Research
  • Virginia Clinical Research, Inc.
  • Guildford Dermatology Specialist
  • Dermadvances Research
  • Lynderm Research, Inc.
  • North Bay Dermatology Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Tazarotene foam, 0.1%

Vehicle Foam

Outcomes

Primary Outcome Measures

Absolute Change in Lesion Counts (LCs) From Baseline to Week 12
LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.
Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Number of Participants With an ISGA Score of 0 or 1 at Week 12
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.

Secondary Outcome Measures

Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12
LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.
Absolute Change From Baseline in LC at Weeks 2, 4, and 8
LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.
Time to a 50 Percent Reduction in Total Lesion Counts (TLC)
Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.
Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12
An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.
Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12
A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline.
Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12
A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline.
Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12
A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline.
Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12
An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline.
Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12
A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline.
Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older
The DLQI was used to measure how much the participants' skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-5=small effect on the participant's life; 6-10=moderate effect on the participant's life; 11-20=very large effect on the participant's life; 21-30=extremely large effect on the participant's life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.
Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger
The CDLQI was used to measure how much the participants' skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-6=small effect on the participant's life; 7-12=moderate effect on the participant's life; 13-18=very large effect on the participant's life; 19-30=extremely large effect on the participant's life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator
Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator
Dryness=skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of dryness reported at any time during treatment.
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator
Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants
Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants
Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.

Full Information

First Posted
November 19, 2009
Last Updated
April 17, 2017
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01017120
Brief Title
A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne
Official Title
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2009 (undefined)
Primary Completion Date
November 1, 2010 (Actual)
Study Completion Date
November 9, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.
Detailed Description
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2, 4, 8, and 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
742 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Tazarotene foam, 0.1%
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle Foam
Intervention Type
Drug
Intervention Name(s)
Tazarotene Foam
Intervention Description
Tazarotene foam once a day application to the face
Intervention Type
Drug
Intervention Name(s)
Vehicle Foam
Intervention Description
Vehicle Foam once a day application to the face
Primary Outcome Measure Information:
Title
Absolute Change in Lesion Counts (LCs) From Baseline to Week 12
Description
LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.
Time Frame
Baseline (Week 0/Day 1) and Week 12
Title
Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12
Description
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame
Baseline (Week 0/Day 1) and Week 12
Title
Number of Participants With an ISGA Score of 0 or 1 at Week 12
Description
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12
Description
LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.
Time Frame
Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Title
Absolute Change From Baseline in LC at Weeks 2, 4, and 8
Description
LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.
Time Frame
Baseline (Week 0/Day 1); Weeks 2, 4, and 8
Title
Time to a 50 Percent Reduction in Total Lesion Counts (TLC)
Description
Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.
Time Frame
Baseline (Week 0/Day 1) to Week 12
Title
Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8
Description
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame
Baseline (Week 0/Day 1); Weeks 2, 4, and 8
Title
Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8
Description
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame
Weeks 2, 4, and 8
Title
Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12
Description
An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.
Time Frame
Weeks 2, 4, 8, and 12
Title
Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12
Description
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame
Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Title
Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12
Description
A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline.
Time Frame
Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Title
Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12
Description
A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline.
Time Frame
Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Title
Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12
Description
A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline.
Time Frame
Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Title
Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12
Description
An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline.
Time Frame
Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Title
Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12
Description
A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline.
Time Frame
Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Title
Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older
Description
The DLQI was used to measure how much the participants' skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-5=small effect on the participant's life; 6-10=moderate effect on the participant's life; 11-20=very large effect on the participant's life; 21-30=extremely large effect on the participant's life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.
Time Frame
Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Title
Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger
Description
The CDLQI was used to measure how much the participants' skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-6=small effect on the participant's life; 7-12=moderate effect on the participant's life; 13-18=very large effect on the participant's life; 19-30=extremely large effect on the participant's life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.
Time Frame
Baseline (Week 0/Day 1); Week 2, 4, 8, and 12
Title
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator
Description
Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.
Time Frame
Baseline (Week 0/Day 1) to Week 12
Title
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator
Description
Dryness=skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of dryness reported at any time during treatment.
Time Frame
Baseline (Week 0/Day 1) to Week 12
Title
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator
Description
Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.
Time Frame
Baseline (Week 0/Day 1) to Week 12
Title
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants
Description
Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.
Time Frame
Baseline (Week 0/Day 1) to Week 12
Title
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants
Description
Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.
Time Frame
Baseline (Week 0/Day 1) to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female age 12 through 45 years, inclusive, who is in good general health. An ISGA score of 3 or greater at baseline. Lesion counts meeting both of the following criteria: Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular lesion (<5mm), with NO cystic lesions. Between 30 and 125 facial noninflammatory lesions, excluding nasal lesions. - Regular menstrual cycle prior to study entry for females of childbearing potential. Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Women who are not currently sexually active must agree to use medically accepted method of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed. Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. Exclusion Criteria: Female who is pregnant, trying to become pregnant, or breast feeding. Use of topical antibiotics on the face within the past 2 weeks. Use of systemic antibiotics for acne treatment within the past 4 weeks. Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines) because of the possibility of augmented photosensitivity. Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks. Use of systemic retinoids (eg, isotretinoin) within the past 6 months. Treatment with estrogens, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to study enrollment. Subjects that have been treated with these medications for more than 12 consecutive weeks prior to study enrollment are allowed to enroll as long as they do not expect to change the dose or drug, or to discontinue use during the study and it has not been indicated for the treatment of acne vulgaris. Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, or salicylates) within the past 2 weeks. Concomitant use of facial products such as: abradants, facials, peels containing glycolic or other acids, masks, washes or soaps. Concomitant use of medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins, haloperidol, and immunosuppressants such as cyclosporine) as these may impact efficacy assessments. Multivitamins, iron supplements, and folate are acceptable. Facial procedure (eg, blue light, chemical or laser peel, or microdermabrasion) within the past 4 weeks. Require or desire excessive or prolonged exposure to ultraviolet light during the study. Known hypersensitivity or previous allergic reaction to any of the active components of the study product. A significant medical history of or currently immunocompromised. Use of any investigational product within the past 4 weeks or currently participating in another clinical study. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study. Any major illness within 30 days before study enrollment. Currently lives in the same household as currently enrolled subjects; is an employee of Stiefel, an investigator, or a CRO involved in the study; or is an immediate family member (eg, partner, offspring, parents) of an employee involved in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
The Laser Institute for Dermatology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
FXM Research Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Atlanta Dermatology & Vein Research Center, PC
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Gwinnett Clinical Research Center, Inc.
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Hudson Dermatology
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Somerset Skin Centre
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Skin Specialists, P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Dermatology Associates of Rochester, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Suzanne Bruce and Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Guildford Dermatology Specialist
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Dermadvances Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1R4
Country
Canada
Facility Name
Lynderm Research, Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B3Z7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
23652892
Citation
Feldman SR, Werner CP, Alio Saenz AB. The efficacy and tolerability of tazarotene foam, 0.1%, in the treatment of acne vulgaris in 2 multicenter, randomized, vehicle-controlled, double-blind studies. J Drugs Dermatol. 2013 Apr;12(4):438-46.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114576
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114576
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114576
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114576
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114576
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114576
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114576
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne

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