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| Sponsor: | Federal University of São Paulo |
|---|---|
| Information provided by: | Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT00701740 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Photoaging Epidermal p53 Expression |
Drug: oral isotretinoin and Mexoryl SX / XL Drug: Mexoryl XL / SX |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 32 |
| Study Start Date: | July 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
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
|
|
B: Active Comparator
11 subjects received only the same moisturizer/sunscreen
|
Drug: Mexoryl XL / SX
11 subjects used only the same moisturizer and SPF 60 sunscreen
|
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| Ages Eligible for Study: | 40 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil, SP | |
| Federal University of Sao Paulo | |
| Sao Paulo, SP, Brazil, 04023-900 | |
| Principal Investigator: | Edileia Bagatin, MD, PHD | Federal University of Sao Paulo |
More Information
| Responsible Party: | Federal University of Sao Paulo ( Edileia Bagatin , MD, PHD ) |
| Study ID Numbers: | UNIFESP |
| Study First Received: | June 18, 2008 |
| Last Updated: | June 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00701740 History of Changes |
| Health Authority: | Brazil: Ethics Committee |
|
photoaging isotretinoin profilometry digital analysis |
|
Terephthalylidene dicamphor sulfonic acid Radiation-Protective Agents Skin Diseases Therapeutic Uses Physiological Effects of Drugs |
Sunscreening Agents Isotretinoin Protective Agents Dermatologic Agents Pharmacologic Actions |
