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

NCT ID: NCT00701740

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-06-30

Brief 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.

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.

Conditions

Photoaging; Epidermal p53 Expression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

oral isotretinoin and Mexoryl SX / XL

Intervention Type: DRUG

20mg, 3/week,continuously for three months

B

11 subjects received only the same moisturizer/sunscreen

Group Type: ACTIVE_COMPARATOR

Mexoryl XL / SX

Intervention Type: DRUG

11 subjects used only the same moisturizer and SPF 60 sunscreen

Interventions

oral isotretinoin and Mexoryl SX / XL

20mg, 3/week,continuously for three months

Intervention Type: DRUG

Mexoryl XL / SX

11 subjects used only the same moisturizer and SPF 60 sunscreen

Intervention Type: DRUG

Other Intervention Names

isotretinoin; mexoryl; mexoryl

Eligibility Criteria

Inclusion Criteria

• menopausal or sterilized women

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Edileia Bagatin

Edileia Bagatin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edileia Bagatin, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

UNIFESP

Identifier Type: -

Identifier Source: org_study_id