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:

Information provided by (Responsible Party):

Anna Chien, Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01283464

First received: January 24, 2011

Last updated: March 7, 2016

Last verified: March 2016

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

Drug Information available for: Retinol Vitamin A palmitate Tretinoin 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 (Adult, Senior)
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

More Information


Responsible Party:	Anna Chien, Assistant Professor, Johns Hopkins University
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:	March 7, 2016
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 Antineoplastic Agents Keratolytic Agents Dermatologic Agents Vitamins	Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents

ClinicalTrials.gov processed this record on September 28, 2016

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