search
Back to results

Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
clindamycin / benzoyl peroxide gel
clindamycin gel
BPO gel
vehicle gel
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 Vulgaris, Acne

Eligibility Criteria

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

Inclusion Criteria:

  • Be 12 to 45 years of age, inclusive, and in good general health.
  • Clinical diagnosis of acne vulgaris
  • Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
  • Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
  • Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.

Exclusion Criteria:

  • Are pregnant or breast-feeding.
  • Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes.
  • Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks.
  • Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
  • Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks.
  • Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
  • Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks.
  • Used abradents or facial procedures, within the past 2 weeks.
  • Use medications that may exacerbate acne.
  • Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product.
  • Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.

Sites / Locations

  • Rady Children's Hospital San Diego, Div. of Pediatric & Adolescents Dermatology
  • The Laser Institute for Dermatology
  • Cherry Creek Research, Inc.
  • Skin Care Research, Inc.
  • University of Miami Cosmetic Medicine and Research Institute
  • FXM Research
  • Atlanta Dermatology & Vein Research Center, LLC
  • SKINQRI
  • Dawes Fretzin Clinical Research Group
  • DermResearch, PLLC
  • Somerset Skin Centre
  • Dermatology Associates of Rochester, PC
  • DermResearch Center of New York
  • The Skin Wellness Center, PC
  • Arlington Center for Dermatology
  • Progressive Clinical Research
  • Dermatology and Skin Care Center FXM Research International
  • Dr. Moguel's Clinic/FXM Research International
  • Guildford Dermatology Specialist
  • Dermatrial Research
  • Lynderm Research, Inc.
  • North Bay Dermatology Centre
  • CRDQ Centre de Recherche Dermatologique du Quebec
  • Nexus Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

clindamycin / benzoyl peroxide gel

Clindamycin gel

BPO gel

vehicle gel

Outcomes

Primary Outcome Measures

Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
Mean Change From Baseline to Week 12 in Total Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.

Secondary Outcome Measures

Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.
Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Mean Change From Baseline to Week 12 in Temperature
Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Mean Change From Baseline to Week 12 in Pulse Rate
Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.
Mean Duration of Study Product Use
Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.

Full Information

First Posted
October 21, 2008
Last Updated
October 11, 2016
Sponsor
Stiefel, a GSK Company
Collaborators
Rho, Inc., Quintiles, Inc., GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00776919
Brief Title
Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
Official Title
A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
Detailed Description
A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
clindamycin / benzoyl peroxide gel
Arm Title
2
Arm Type
Active Comparator
Arm Description
Clindamycin gel
Arm Title
3
Arm Type
Active Comparator
Arm Description
BPO gel
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
vehicle gel
Intervention Type
Drug
Intervention Name(s)
clindamycin / benzoyl peroxide gel
Intervention Description
Once a day application to the face
Intervention Type
Drug
Intervention Name(s)
clindamycin gel
Intervention Description
Once a day application to the face
Intervention Type
Drug
Intervention Name(s)
BPO gel
Intervention Description
Once a day application to the face
Intervention Type
Drug
Intervention Name(s)
vehicle gel
Intervention Description
Once a day application to the face
Primary Outcome Measure Information:
Title
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
Description
During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Time Frame
Baseline (Day 1) and Week 12
Title
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
Description
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
Time Frame
Baseline (Day 1) and Week 12
Title
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
Description
During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
Time Frame
Baseline (Day 1) and Week 12
Title
Mean Change From Baseline to Week 12 in Total Lesion Counts
Description
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.
Time Frame
Baseline (Day 1) and Week 12
Secondary Outcome Measure Information:
Title
Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Description
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.
Time Frame
Baseline (Day 1) and Week 12
Title
Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
Description
During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.
Time Frame
Week 12
Title
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
Description
During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Time Frame
Week 12
Title
Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
Description
Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time Frame
Baseline (Day 1) and Week 12
Title
Mean Change From Baseline to Week 12 in Temperature
Description
Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time Frame
Baseline (Day 1) and Week 12
Title
Mean Change From Baseline to Week 12 in Pulse Rate
Description
Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time Frame
Baseline (Day 1) and Week 12
Title
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Description
Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.
Time Frame
Baseline; Weeks 2, 4, 8, and 12
Title
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Description
Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.
Time Frame
Baseline; Weeks 2, 4, 8, and 12
Title
Mean Duration of Study Product Use
Description
Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.
Time Frame
Baseline (Day 1) through Week 12
Title
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
Description
An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.
Time Frame
Baseline (Day 1) through 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: Be 12 to 45 years of age, inclusive, and in good general health. Clinical diagnosis of acne vulgaris Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian. Exclusion Criteria: Are pregnant or breast-feeding. Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes. Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks. Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable. Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks. Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study. Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks. Used abradents or facial procedures, within the past 2 weeks. Use medications that may exacerbate acne. Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product. Used any investigational therapy within the past 4 weeks, or currently participating in another clinical 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
Rady Children's Hospital San Diego, Div. of Pediatric & Adolescents Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
The Laser Institute for Dermatology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Cherry Creek Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Skin Care Research, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Miami Cosmetic Medicine and Research Institute
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
FXM Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Atlanta Dermatology & Vein Research Center, LLC
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
SKINQRI
City
Lincolnshire
State/Province
Illinois
ZIP/Postal Code
60069
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
DermResearch, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Somerset Skin Centre
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
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
DermResearch Center of New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
The Skin Wellness Center, PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Arlington Center for Dermatology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology and Skin Care Center FXM Research International
City
Belize City
Country
Belize
Facility Name
Dr. Moguel's Clinic/FXM Research International
City
Belize City
Country
Belize
Facility Name
Guildford Dermatology Specialist
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R6A7
Country
Canada
Facility Name
Dermatrial Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
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
Facility Name
CRDQ Centre de Recherche Dermatologique du Quebec
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Nexus Clinical Research
City
St. John's
ZIP/Postal Code
NL A1B 3E1
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
22134562
Citation
Eichenfield LF, Alio Saenz AB. Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study. J Drugs Dermatol. 2011 Dec;10(12):1382-96.
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
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114677
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
114677
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
114677
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
114677
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
114677
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
114677
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114677
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

We'll reach out to this number within 24 hrs