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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
 Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)
Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 28
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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.
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964223

Locations
United States, Maryland
Aesthetics, Skin Care & Dermasurgery
Rockville, Maryland, United States, 20850
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00964223     History of Changes
Other Study ID Numbers: 114547, C0000-410
Study First Received: August 20, 2009
Results First Received: September 7, 2010
Last Updated: February 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Clindamycin
Clindamycin-2-phosphate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013