Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles

Phase 2

Completed

• Conditions: Photodamaged Skin; Wrinkles
• Interventions: Drug: Retinol; Drug: Tretinoin

• Registration Number: NCT01283464
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this study is to assess the comparative efficacy of retinol 1.0% and tretinoin 0.02% in minimizing wrinkles, discoloration, roughness, and other signs of moderate to severe photodamage. Our hypothesis is that both products will be of comparable benefit.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-26
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2013-04-12
• Results First Submitted QC: 2013-07-19
• Results First Posted: 2013-08-20
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age 35 or over
• Moderate to severe photodamage

Exclusion Criteria

• History of facial cosmetic surgery, facial resurfacing procedures, deep peels, or facial fillers
• History of keloids or hypertrophic scars
• Use of oral steroids or oral retinoids (such as Accutane) in past 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retinol	Retinol	Retinol 1.0% cream
Tretinoin	Tretinoin	Tretinoin 0.02% cream

Primary Outcome Measures

Name	Time	Method
Global Photodamage Severity	Week 24	A photonumeric scale for the assessment of cutaneous photodamage (CE Griffiths, et al). Five photographic standards (en face and 45 degrees oblique) illustrating increasing severity of photodamage (min=0, max=8) where 0=no damamge; 2=mild damage; 4=moderate damage; 6=moderate/severe damage; and grade 8=severe damage.

Trial Locations

Locations (1)

Johns Hopkins Dept. of Dermatology; 🇺🇸 Baltimore, Maryland, United States