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

Phase 2

Completed

• Conditions: Epidermal p53 Expression; Photoaging
• Interventions: Drug: Mexoryl XL / SX; Drug: oral isotretinoin and Mexoryl SX / XL

• Registration Number: NCT00701740
• Lead Sponsor: Federal University of São Paulo

Brief 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.

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 Timeline

• Study Start: 2007-07
• Primary Completion: 2008-01
• Study Completion: 2008-06
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• menopausal or sterilized women

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Mexoryl XL / SX	11 subjects received only the same moisturizer/sunscreen
A	oral isotretinoin and Mexoryl SX / XL	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

Primary Outcome Measures

Name	Time	Method
histological findings	before and after 3 months

Secondary Outcome Measures

Name	Time	Method
laboratory tests	before, after 1 and 3 months

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil