Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles
Double-blinded, Single-center, Parallel-arm Comparison Study of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 24, 2011
CompletedFirst Posted
Study publicly available on registry
January 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
August 20, 2013
CompletedApril 4, 2016
March 1, 2016
1.1 years
January 24, 2011
April 12, 2013
March 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Retinol
ACTIVE COMPARATORRetinol 1.0% cream
Tretinoin
ACTIVE COMPARATORTretinoin 0.02% cream
Interventions
Eligibility Criteria
You may qualify if:
- Age 35 or over
- Moderate to severe photodamage
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Dept. of Dermatology
Baltimore, Maryland, 21231, United States
Related Publications (1)
Chien AL, Kim DJ, Cheng N, Shin J, Leung SG, Nelson AM, Zang J, Suh H, Rainer B, Wallis L, Okoye GA, Loss M, Kang S. Biomarkers of Tretinoin Precursors and Tretinoin Efficacy in Patients With Moderate to Severe Facial Photodamage: A Randomized Clinical Trial. JAMA Dermatol. 2022 Aug 1;158(8):879-886. doi: 10.1001/jamadermatol.2022.1891.
PMID: 35675051DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Anna L. Chien
- Organization
- Johns Hopkins Dermatology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 24, 2011
First Posted
January 26, 2011
Study Start
November 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
April 4, 2016
Results First Posted
August 20, 2013
Record last verified: 2016-03