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A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)
benzoyl peroxide and adapalene gel (EPIDUO™ 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
  • 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.
  • Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
  • Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.

Exclusion Criteria:

  • Female subjects who are pregnant, trying to become pregnant or breastfeeding.
  • Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris.
  • Facial hair that may obscure the accurate assessment of acne grade.
  • History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
  • Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
  • Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
  • Use of systemic retinoids within the past 6 months.
  • Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
  • Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
  • Use of topical anti-acne medications within the past 2 weeks.
  • Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.

Sites / Locations

  • Aesthetics, Skin Care & Dermasurgery
  • Grekin Skin Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Duac gel

Epiduo gel

Arm Description

Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.

Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.

Outcomes

Primary Outcome Measures

Skin Dryness Score
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Skin Peeling Score
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.
Irritant/Allergic Contact Dermatitis Score
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None Slight Moderate Intense
Erythema (Redness) Score
Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Secondary Outcome Measures

Erythema (Redness) Score
Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Skin Dryness Score
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Skin Peeling Score
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Irritant/Allergic Contact Dermatitis Score
Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Investigator Static Global Assessment Score
ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.
Inflammatory Acne Lesion Counts
Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Non-Inflammatory Acne Lesion Counts
Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Total Acne Lesion Counts
Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Skindex-29 Quality of Life Questionnaire - Emotional Domain
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Skindex-29 Quality of Life Questionnaire - Functional Domain
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Skindex-29 Quality of Life Questionnaire - Global Score
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain.
Product Acceptability and Preference Questionnaire - Severity of Redness
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Product Acceptability and Preference Questionnaire - Severity of Redness
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Product Acceptability and Preference Questionnaire - Severity of Dryness
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Product Acceptability and Preference Questionnaire - Severity of Dryness
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Product Acceptability and Preference Questionnaire - Severity of Burning
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Product Acceptability and Preference Questionnaire - Severity of Burning
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Product Acceptability and Preference Questionnaire - Severity of Itching
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Product Acceptability and Preference Questionnaire - Severity of Itching
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Product Acceptability and Preference Questionnaire - Severity of Scaling
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Product Acceptability and Preference Questionnaire - Severity of Scaling
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
Product Acceptability and Preference Questionnaire - Comfort of Skin
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.
Product Acceptability and Preference Questionnaire - Comfort of Skin
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.
Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.
Product Acceptability and Preference Questionnaire - Compliance
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).
Product Acceptability and Preference Questionnaire - Compliance
Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.

Full Information

First Posted
August 20, 2009
Last Updated
October 11, 2016
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00964223
Brief Title
A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
Official Title
A Single-blind, Randomized, Comparative Split-face Study Evaluating the Tolerability of Clindamycin and Benzoyl Peroxide Gel to Benzoyl Peroxide/Adapalene Gel in the Treatment of Acne Vulgaris.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (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
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Detailed Description
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3 subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks. Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duac gel
Arm Type
Experimental
Arm Description
Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.
Arm Title
Epiduo gel
Arm Type
Active Comparator
Arm Description
Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)
Other Intervention Name(s)
Duac® Topical Gel
Intervention Description
Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.
Intervention Type
Drug
Intervention Name(s)
benzoyl peroxide and adapalene gel (EPIDUO™ Gel)
Other Intervention Name(s)
EPIDUO™ Gel
Intervention Description
Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.
Primary Outcome Measure Information:
Title
Skin Dryness Score
Description
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame
Week 1, Week 2
Title
Skin Peeling Score
Description
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.
Time Frame
Week 1, Week 2
Title
Irritant/Allergic Contact Dermatitis Score
Description
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None Slight Moderate Intense
Time Frame
Week 1, Week 2
Title
Erythema (Redness) Score
Description
Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame
Week 1, Week 2
Secondary Outcome Measure Information:
Title
Erythema (Redness) Score
Description
Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame
Week 5, Week 8
Title
Skin Dryness Score
Description
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame
Week 5, Week 8
Title
Skin Peeling Score
Description
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame
Week 5, Week 8
Title
Irritant/Allergic Contact Dermatitis Score
Description
Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame
Week 5, Week 8
Title
Investigator Static Global Assessment Score
Description
ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.
Time Frame
Week 5, Week 8
Title
Inflammatory Acne Lesion Counts
Description
Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Time Frame
Week 5, Week 8
Title
Non-Inflammatory Acne Lesion Counts
Description
Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Time Frame
Week 5, Week 8
Title
Total Acne Lesion Counts
Description
Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Time Frame
Week 5, Week 8
Title
Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
Description
Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Time Frame
Baseline, and Week 8
Title
Skindex-29 Quality of Life Questionnaire - Emotional Domain
Description
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Time Frame
Baseline, and Week 8
Title
Skindex-29 Quality of Life Questionnaire - Functional Domain
Description
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Time Frame
Baseline, and Week 8
Title
Skindex-29 Quality of Life Questionnaire - Global Score
Description
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain.
Time Frame
Baseline, and Week 8
Title
Product Acceptability and Preference Questionnaire - Severity of Redness
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Severity of Redness
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Severity of Dryness
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Severity of Dryness
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Severity of Burning
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Severity of Burning
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Severity of Itching
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Severity of Itching
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Severity of Scaling
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Severity of Scaling
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Comfort of Skin
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Comfort of Skin
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Compliance
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Compliance
Description
Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Description
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Description
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Description
Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Description
Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Description
Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.
Time Frame
Week 8
Title
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Description
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.
Time Frame
Week 1, Week 2
Title
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Description
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris. 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. Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed. Exclusion Criteria: Female subjects who are pregnant, trying to become pregnant or breastfeeding. Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris. Facial hair that may obscure the accurate assessment of acne grade. History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms. Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively. Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable. Use of systemic retinoids within the past 6 months. Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity. Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents. Use of topical anti-acne medications within the past 2 weeks. Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.
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
Aesthetics, Skin Care & Dermasurgery
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States

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
23174047
Citation
Gonzalez P, Vila R, Cirigliano M. The tolerability profile of clindamycin 1%/benzoyl peroxide 5% gel vs. adapalene 0.1%/benzoyl peroxide 2.5% gel for facial acne: results of a randomized, single-blind, split-face study. J Cosmet Dermatol. 2012 Dec;11(4):251-60. doi: 10.1111/jocd.12013.
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114547
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
114547
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
114547
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
114547
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
114547
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
114547
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
114547
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 Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

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