Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial
Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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
Ending date: June 2008
Last updated: June 18, 2008
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