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

• ClinicalTrials.gov Identifier: NCT00964223
• Recruitment Status: Completed
• First Posted: August 24, 2009
• Results First Posted: August 25, 2011
• Last Update Posted: November 23, 2016
• Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline ( Stiefel, a GSK Company )

Tracking Information

• First Submitted Date: August 20, 2009
• First Posted Date: August 24, 2009
• Results First Submitted Date: September 7, 2010
• Results First Posted Date: August 25, 2011
• Last Update Posted Date: November 23, 2016
• Study Start Date: July 2009
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 14, 2015)

• Skin Dryness Score [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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

  1. Slight
  2. Moderate
  3. Intense
• Erythema (Redness) Score [ Time Frame: Week 1, Week 2 ]
  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.

• Original Primary Outcome Measures (submitted: August 21, 2009): To compare the tolerability of clindamycin and benzoyl peroxide gel to benzoyl peroxide/adapalene gel in the treatment of facial acne during the first 2 weeks of treatment. [ Time Frame: 2 Weeks ]
• Change History: Complete list of historical versions of study NCT00964223 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 14, 2015)

• Erythema (Redness) Score [ Time Frame: Week 5, Week 8 ]
  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 [ Time Frame: Week 5, Week 8 ]
  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 [ Time Frame: Week 5, Week 8 ]
  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 [ Time Frame: Week 5, Week 8 ]
  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 [ Time Frame: Week 5, Week 8 ]
  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 [ Time Frame: Week 5, Week 8 ]
  Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
• Non-Inflammatory Acne Lesion Counts [ Time Frame: Week 5, Week 8 ]
  Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
• Total Acne Lesion Counts [ Time Frame: Week 5, Week 8 ]
  Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
• Skindex-29 Quality of Life Questionnaire - Symptomatic Domain [ Time Frame: Baseline, and Week 8 ]
  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 [ Time Frame: Baseline, and Week 8 ]
  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 [ Time Frame: Baseline, and Week 8 ]
  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 [ Time Frame: Baseline, and Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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? [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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 [ Time Frame: Week 1, Week 2 ]
  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 [ Time Frame: Week 8 ]
  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.

• Original Secondary Outcome Measures (submitted: August 21, 2009): To evaluate efficacy, tolerability, safety and subject satisfaction of clindamycin and benzoyl peroxide gel in the treatment of acne vulgaris. To evaluate the influence of acne on subjects' quality of life. [ Time Frame: 8 Weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)
  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.
  Other Name: Duac® Topical Gel
• Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)
  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.
  Other Name: EPIDUO™ Gel

Study Arms

• Experimental: Duac gel
  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: Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)
• Active Comparator: Epiduo gel
  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: Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 21, 2010): 28
• Original Estimated Enrollment (submitted: August 21, 2009): 45
• Actual Study Completion Date: November 2009
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00964223
• Other Study ID Numbers: 114547
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.

• Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
• Study Sponsor: Stiefel, a GSK Company
• Collaborators: GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: October 2016