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

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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
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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
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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
U.S. FDA Resources

Arms and Interventions
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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
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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
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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
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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
United States, Maryland
Johns Hopkins Dept. of Dermatology
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Anna Chien, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01283464     History of Changes
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:
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