Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel

Galderma

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Retin-A Micro Microsphere 0.1%; Drug: Epiduo Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01522456

US10201

Details and patient eligibility

About

To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.

Full description

Adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (22 days). Tolerability assessments (erythema, dryness, scaling, stinging/burning)on both sides of the face will be taken on each visit, on each weekday from from baseline to day 22. The investigator and subjects will respond to user preference questions on days 5, 12, 19, and 22.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects of any race
• Subjects 18 years or older
• Subjects with acne vulgaris

Exclusion criteria

• Subjects with an allergy to a component of the study drugs (refer to the package inserts for Epiduo Gel and Retin-A Micro 0.1%)
• Subjects with a washout period for topical treatment (less than 1 week for corticosteroids or 4 weeks for retinoids)
• Subjects with a washout period for systemic treatment (less than 1 week for medications that may have increased photosensitivity or 4 weeks for corticosteroids or 24 weeks for oral retinoids)
• Subjects with a sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the treatment area
• Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

73 participants in 2 patient groups

Epiduo Gel

Active Comparator group

Description:

Adapalene 0.1% and benzoyl peroxide 2.5% gel

Treatment:

Drug: Epiduo Gel

Retin-A Micro Microsphere 0.1%

Active Comparator group

Description:

Tretinoin gel, 0.1%

Treatment:

Drug: Retin-A Micro Microsphere 0.1%