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

NCT ID: NCT00647556

Last Updated: 2022-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Same as above.

Conditions

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Photoaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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adapalene

adapalene

Group Type ACTIVE_COMPARATOR

adapalene gel, 0.3%

Intervention Type DRUG

applied topically once daily in the evening

tretinoin

Tretinoin

Group Type ACTIVE_COMPARATOR

tretinoin 0.05% emollient cream

Intervention Type DRUG

applied topically once daily in the evening

Interventions

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adapalene gel, 0.3%

applied topically once daily in the evening

Intervention Type DRUG

tretinoin 0.05% emollient cream

applied topically once daily in the evening

Intervention Type DRUG

Other Intervention Names

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Differin® 0.3% Gel tretinoin emollient cream 0.05%

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald W Gottschalk, MD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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University of Michigan Department of Dermatology

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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US10067

Identifier Type: -

Identifier Source: org_study_id

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