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

August 13, 2018 updated by: Edileia Bagatin, Federal University of São Paulo

Phase II Randomized Controlled Trial to Evaluate the Clinical and Histological Effects of Oral Isotretinoin for the Treatment of Photoaging on Face and Forearms

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical assessment ranging from -2=very bad to +2=very good for all patients. Also, profilometry, corneometer and skin elasticity tests in periocular regions and left forearm; skin biopsy on left forearm before/after treatment in B and in 10 randomly selected patients from A. Microscopic evaluation of corneal layer and epidermal thickness, dermal elastosis, new collagen and p53 epidermal expression performed by quantitative digital image analysis. Blind evaluations (group/time) conducted by two independent observers.

Clinical evaluation results showed no alterations (0) or slight improvement (+1) for all patients; profilometry, corneometer and skin elasticity measurements presented a significant difference in pre and post treatment values (p=0,001 to 0,028) with no differences between A/B. Regarding histological findings and p53 expression no previous differences between groups before the treatment were observed (p>0,1).Quantitative microscopic digital analysis demonstrated no differences between groups at the end of the study for the majority of variables. However, slight but significant difference between A/B subjects was found for p53 with major expression reduction for those treated with oral isotretinoin [0,66±0,31 vs 0,94±0,34 respectively (p=0,04)]. The main side effects were cheilitis in 15 patients (75%) and xerophthalmia in 5 (25%). No significant alterations occurred in biochemical tests.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-900
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • menopausal or sterilized women

Exclusion Criteria:

  • woman at risk of pregnancy, with alterations on liver function or lipid profile

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
A - 21 subjects were treated 20mg isotretinoin 3/week plus moisturizer and sunscreen,for three months; 10 randomly selected were submitted to skin biopsies before and after the end of treatment
Drug: oral isotretinoin and Mexoryl SX / XL
20mg, 3/week,continuously for three months
Other Names:
  • isotretinoin
  • mexoryl
ACTIVE_COMPARATOR: B
11 subjects received only the same moisturizer/sunscreen
Drug: Mexoryl XL / SX
11 subjects used only the same moisturizer and SPF 60 sunscreen
Other Names:
  • mexoryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
histological findings
Time Frame: before and after 3 months
before and after 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
laboratory tests
Time Frame: before, after 1 and 3 months
before, after 1 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Edileia Bagatin, MD, PHD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (ESTIMATE)

June 19, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIFESP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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