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

Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Photoaging; Epidermal p53 Expression

Intervention: oral isotretinoin and Mexoryl SX / XL (Drug); Mexoryl XL / SX (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Edileia Bagatin, MD, PHD, Principal Investigator, Affiliation: Federal University of Sao Paulo

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: histological findings

Secondary outcome: laboratory tests

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.

Eligibility

Minimum age: 40 Years. Maximum age: 55 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- menopausal or sterilized women

Exclusion Criteria:

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

Locations and Contacts

Federal University of Sao Paulo, Sao Paulo, SP 04023-900, Brazil
Additional Information

Starting date: July 2007
Last updated: June 18, 2008

Page last updated: August 23, 2015

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