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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:
Collaborator:
SkinMedica
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01283464
First received: January 24, 2011
Last updated: July 19, 2013
Last verified: January 2011
History of Changes
  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: Double Blind (Subject, 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:

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Global Photodamage Severity [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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
Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283464

Locations
United States, Maryland
Johns Hopkins Dept. of Dermatology
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
SkinMedica
  More Information

Additional Information:
SkinMedica, Inc., company website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Anna Chien, M.D., Johns Hopkins University Dept. of Dermatology
ClinicalTrials.gov Identifier: NCT01283464     History of Changes
Other Study ID Numbers: SKM10-R-01
Study First Received: January 24, 2011
Results First Received: April 12, 2013
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Retinol
Tretinoin

Additional relevant MeSH terms:
Retinol palmitate
Tretinoin
Vitamin A
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Dermatologic Agents
Growth Substances
 Keratolytic Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on March 03, 2015