Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel
Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Epiduo Gel (Drug); Retin-A Micro Microsphere 0.1% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Galderma Laboratories, L.P. Official(s) and/or principal investigator(s):
Ronald Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.
Summary
To compare the tolerability of EpiduoŽ (adapalene and benzoyl peroxide) Gel 0. 1%/2. 5% to
Retin-A MicroŽ (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.
Clinical Details
Official title: Split-face Tolerability Comparison Between EpiduoŽ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Versus Retin-A MicroŽ (Tretinoin Gel) Microsphere, 0.1% in Subjects With Acne Vulgaris
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Worst Postbaseline Tolerability (Erythema)Worst Postbaseline Tolerability (Scaling) Worst Postbaseline Tolerability (Dryness) Worst Postbaseline Tolerability (Stinging/Burning)
Secondary outcome: Tolerability at Day 22 (Erythema)Tolerability at Day 22 (Dryness) Tolerability at Day 22 (Scaling) Tolerability at Day 22 (Stinging/Burning) Cumulative Tolerability (Erythema) Cumulative Tolerability (Scaling) Cumulative Tolerability (Dryness) Cumulative Tolerability (Stinging/Burning) Cumulative Tolerability (Combined)
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Stephens and Associates, Dallas, Texas 75006, United States
Additional Information
Starting date: April 2012
Last updated: August 10, 2015
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