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

Photoaging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701740
• Other study ID #: UNIFESP
• Status: Completed
• Phase: Phase 2
• Start date: July 2007
• Est. completion date: June 2008

Study information

• Verified date: August 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• menopausal or sterilized women

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Epidermal p53 Expression
• Photoaging
• Skin Diseases

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histological findings		before and after 3 months
Secondary	laboratory tests		before, after 1 and 3 months