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

NCT ID: NCT01283464

Last Updated: 2016-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Photodamaged Skin Wrinkles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Retinol

Retinol 1.0% cream

Group Type ACTIVE_COMPARATOR

Retinol

Intervention Type DRUG

1.0% cream

Tretinoin

Tretinoin 0.02% cream

Group Type ACTIVE_COMPARATOR

Tretinoin

Intervention Type DRUG

0.02% cream

Interventions

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Retinol

1.0% cream

Intervention Type DRUG

Tretinoin

0.02% cream

Intervention Type DRUG

Other Intervention Names

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Retin-A Renova Atralin Aberela Airol Avita Stieva-A

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Anna Chien

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johns Hopkins Dept. of Dermatology

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Chien AL, Kim DJ, Cheng N, Shin J, Leung SG, Nelson AM, Zang J, Suh H, Rainer B, Wallis L, Okoye GA, Loss M, Kang S. Biomarkers of Tretinoin Precursors and Tretinoin Efficacy in Patients With Moderate to Severe Facial Photodamage: A Randomized Clinical Trial. JAMA Dermatol. 2022 Aug 1;158(8):879-886. doi: 10.1001/jamadermatol.2022.1891.

Reference Type DERIVED
PMID: 35675051 (View on PubMed)

Related Links

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http://www.skinmedica.com

SkinMedica, Inc., company website

Other Identifiers

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SKM10-R-01

Identifier Type: -

Identifier Source: org_study_id

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