Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel
Status: | Completed |
---|---|
Conditions: | Acne, Acne, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | April 2012 |
End Date: | May 2012 |
Split-face Tolerability Comparison Between Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Versus Retin-A Micro® (Tretinoin Gel) Microsphere, 0.1% in Subjects With Acne Vulgaris
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.
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.
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.
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.
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)
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