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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01283464
First Posted: January 26, 2011
Last Update Posted: April 4, 2016
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.
Information provided by (Responsible Party):
Anna Chien, Johns Hopkins University
  Purpose
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 Intervention Phase
Photodamaged Skin Wrinkles Drug: Retinol Drug: Tretinoin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Anna Chien, Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Enrollment: 24
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
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
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
United States, Maryland
Johns Hopkins Dept. of Dermatology
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
  More Information

Additional Information:
Responsible Party: Anna Chien, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01283464     History of Changes
Other Study ID Numbers: SKM10-R-01
First Submitted: January 24, 2011
First Posted: January 26, 2011
Results First Submitted: April 12, 2013
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:
Retinol palmitate
Tretinoin
Vitamin A
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents