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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Tracking Information
First Submitted Date  ICMJE August 20, 2009
First Posted Date  ICMJE August 24, 2009
Results First Submitted Date  ICMJE September 7, 2010
Results First Posted Date  ICMJE August 25, 2011
Last Update Posted Date November 23, 2016
Study Start Date  ICMJE July 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2010)
28
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2009)
45
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00964223
Other Study ID Numbers  ICMJE 114547
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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  ICMJE Stiefel, a GSK Company
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP