We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01283464
Recruitment Status : Completed
First Posted : January 26, 2011
Results First Posted : August 20, 2013
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Anna Chien, Johns Hopkins University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Photodamaged Skin Wrinkles Drug: Retinol Drug: Tretinoin Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Retinol
Retinol 1.0% cream
 Drug: Retinol
1.0% cream
Active Comparator: Tretinoin
Tretinoin 0.02% cream
 Drug: Tretinoin
0.02% cream
Other Names:
  • Retin-A
  • Renova
  • Atralin
  • Aberela
  • Airol
  • Avita
  • Stieva-A


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Global Photodamage Severity [ Time Frame: 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283464


Locations
Layout table for location information
United States, Maryland
Johns Hopkins Dept. of Dermatology
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Anna Chien, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01283464    
Other Study ID Numbers: SKM10-R-01
First Posted: January 26, 2011    Key Record Dates
Results First Posted: August 20, 2013
Last Update Posted: April 4, 2016
Last Verified: March 2016
Keywords provided by Anna Chien, Johns Hopkins University:
Retinol
Tretinoin
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin A
Tretinoin
Antineoplastic Agents
Keratolytic Agents
 Dermatologic Agents
Vitamins
Micronutrients
Physiological Effects of Drugs