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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Photodamaged Skin Wrinkles | Drug: Retinol Drug: Tretinoin | Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Retinol
Retinol 1.0% cream
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Drug: Retinol
1.0% cream |
Active Comparator: Tretinoin
Tretinoin 0.02% cream
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Drug: Tretinoin
0.02% cream
Other Names:
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- 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.

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Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Maryland | |
Johns Hopkins Dept. of Dermatology | |
Baltimore, Maryland, United States, 21231 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Retinol Tretinoin |
Vitamin A Tretinoin Antineoplastic Agents Keratolytic Agents |
Dermatologic Agents Vitamins Micronutrients Physiological Effects of Drugs |