Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00964223
First received: August 20, 2009
Last updated: February 23, 2012
Last verified: February 2012

August 20, 2009
February 23, 2012
July 2009
December 2009   (final data collection date for primary outcome measure)
  • Erythema (Redness) Score [ Time Frame: Week 1, Week 2 ] [ Designated as safety issue: No ]
    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 1, Week 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00964223 on ClinicalTrials.gov Archive Site
  • Erythema (Redness) Score [ Time Frame: Week 5, Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Total number of inflammatory acne lesions (pustules, papules) at each time point.
  • Non-Inflammatory Acne Lesion Counts [ Time Frame: Week 5, Week 8 ] [ Designated as safety issue: No ]
    Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each time point.
  • Total Acne Lesion Counts [ Time Frame: Week 5, Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Acne Vulgaris
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00964223
114547, C0000-410
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
Stiefel, a GSK Company
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2012

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