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Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial

NCT00701740 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-08-15

No results posted yet for this study

Summary

A clinical and histological randomized controlled phase II trial to evaluate the efficacy and safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A- 21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three months; B- 11 women received only same moisturizer/sunscreen.

Conditions

  • Photoaging
  • Epidermal p53 Expression

Interventions

DRUG

oral isotretinoin and Mexoryl SX / XL

20mg, 3/week,continuously for three months

DRUG

Mexoryl XL / SX

11 subjects used only the same moisturizer and SPF 60 sunscreen

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Edileia Bagatin, MD, PHD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-01-31
Completion
2008-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00701740 on ClinicalTrials.gov