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

Wrinkles Clinical Trial

Official title:

Double-blinded, Single-center, Parallel-arm Comparison Study of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283464
• Other study ID #: SKM10-R-01
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2011
• Last updated: July 19, 2013
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2011
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Photodamaged Skin
• Wrinkles

Intervention

Drug:
• Retinol
1.0% cream
• Tretinoin
0.02% cream

Locations

Country	Name	City	State
United States	Johns Hopkins Dept. of Dermatology	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	SkinMedica

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Photodamage Severity	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.	Week 24	No