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

Stiefel

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel); Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00964223

114547

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Duac gel

Experimental group

Description:

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.

Treatment:

Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)

Epiduo gel

Active Comparator group

Description:

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.

Treatment:

Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)