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

NCT00964223 | Completed Phase 4 Results

• 1 other identifier: 114547
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Vulgaris

Keywords

Acne vulgaris

Outcome Measures

Primary Outcomes (4)

• Skin Dryness Score

  Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

  Week 1, Week 2

• Skin Peeling Score

  Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.

  Week 1, Week 2

• Irritant/Allergic Contact Dermatitis Score

  Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None 1. Slight 2. Moderate 3. Intense

  Week 1, Week 2

• Erythema (Redness) Score

  Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

  Week 1, Week 2

Secondary Outcomes (40)

• Erythema (Redness) Score

  Week 5, Week 8

• Skin Dryness Score

  Week 5, Week 8

• Skin Peeling Score

  Week 5, Week 8

• Irritant/Allergic Contact Dermatitis Score

  Week 5, Week 8

• Investigator Static Global Assessment Score

  Week 5, Week 8

Study Arms (2)

Duac gel

EXPERIMENTAL

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)

Epiduo gel

ACTIVE COMPARATOR

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)

Interventions

Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) DRUG

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.

Also known as: Duac® Topical Gel

Duac gel

benzoyl peroxide and adapalene gel (EPIDUO™ Gel) DRUG

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.

Also known as: EPIDUO™ Gel

Epiduo gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

Aesthetics, Skin Care & Dermasurgery

Rockville, Maryland, 20850, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Related Publications (1)

• 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.

  PMID: 23174047 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin; Benzoyl Peroxide

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 24, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 23, 2016
• Results First Posted: August 25, 2011

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)