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”

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 Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

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.

Intervention(s) in this Clinical Trial

• Drug: oral isotretinoin and Mexoryl SX / XL
  • 20mg, 3/week,continuously for three months
• Drug: Mexoryl XL / SX
  • 11 subjects used only the same moisturizer and SPF 60 sunscreen

Arms, Groups and Cohorts in this Clinical Trial

• 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
• Active Comparator: B
  • 11 subjects received only the same moisturizer/sunscreen

Primary Measures

• histological findings
  • Time Frame: before and after 3 months
    Safety Issue?: No

Secondary Measures

• laboratory tests
  • Time Frame: before, after 1 and 3 months
    Safety Issue?: Yes

Inclusion Criteria:

• menopausal or sterilized women

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Federal University of São Paulo

Overall Clinical Trial Officials and Contacts

Edileia Bagatin, MD, PHD Principal Investigator Federal University of Sao Paulo  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00701740

Study ID Number: UNIFESP

ClinicalTrials.gov Identifier: NCT00701740

Health Authority: Brazil: Ethics Committee