Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage

Galderma

Status and phase: Completed; Phase 3

Conditions: Photoaging

Treatments: Drug: tretinoin 0.05% emollient cream; Drug: adapalene gel, 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00647556

US10067

Details and patient eligibility

About

The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel 0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with tolerability assessment as a secondary objective.

Full description

Same as above.

Enrollment: 30 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female aged 40 years of age and older with Fitzpatrick skin types I through III
• Clinically moderate to severe photodamage

Exclusion criteria

• Subjects with history of laser resurfacing, dermabrasion, medium or deep chemical peel of the face
• Subjects with diagnosis of skin cancer within 3 months of study entry
• Subjects who have had superficial chemical peels, exfoliation or microdermabrasion of the face within 3 months of study entry
• Subjects who have had botulinum toxin for facial rejuvenation within 6 months of study entry and are unwilling to refrain from botulinum toxin treatments during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

adapalene

Active Comparator group

Description:

adapalene

Treatment:

Drug: adapalene gel, 0.3%

tretinoin

Active Comparator group

Description:

Tretinoin

Treatment:

Drug: tretinoin 0.05% emollient cream