Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

Phase 2

• Conditions: Photodamage; Photoaging
• Interventions: Drug: oral isotretinoin; Drug: Tretinoin

• Registration Number: NCT00842907
• Lead Sponsor: Federal University of São Paulo

Brief Summary

This is a randomized, comparative, single evaluator-blinded trial to evaluate clinical, histological and immunohistochemical effects of oral isotretinoin plus moisturizer sunscreen as compared to the use of 0,05% tretinoin cream plus moisturizer sunscreen for the treatment of photodamage on face and forearms. Main oral isotretinoin safety parameters will also be analyzed, as well as adverse events related to topical products.

Detailed Description

A 24-week study, with 7 or 9 monthly visits, comprising healthy adult volunteers, aged 50 to 75 years will be carried out. The patients should present advanced to severe photodamage on face and forearms. Written informed consent will be obtained from each subject prior to enrollment.

Eligible patients will be randomly divided in two groups:

A- 10 patients will be treated with oral isotretinoin, 20.0 mg/day, every other day, 15 capsules per month, for 24 weeks, associated with the use of moisturizer broad spectrum sunscreen twice a day.

B- 10 patients (controls) will be treated with 0,05% tretinoin cream applied on face and forearms at night and the same moisturizer broad-spectrum sunscreen twice a day.

After randomization, laboratory tests will be requested for patients from group A and will be repeated on weeks 4 and 24.

Study Timeline

• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Status Verified: 2009-04
• Study Start: 2009-05
• Primary Completion: 2009-12
• Last Update Submitted: 2010-06-07
• Last Update Posted: 2010-06-08
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients aged from 50 to 75 years old
• Post-menopausal women for at least one year
• Patients with moderate to severe photodamage on face and arms
• Individuals in generally good health
• Fitzpatrick I to III skin type
• Patients who are willing to avoid sun-exposure during the study period

Exclusion Criteria

• Patients of child bearing potential
• Individuals who have been treated with topical anti-aging products and/or superficial chemical peels within 3 months or received topical tretinoin or oral retinoid (6 months); fillers and/or botulinum toxin applications (4 months); medium-depth chemical peels or ablative lasers or dermabrasion (6 months) and surgical lifting (12 months) will not be eligible for inclusion in the study
• Patients on cytotoxic drugs (including azathioprine, cyclophosphamide, mycophenolate mofetil, or other chemotherapeutic agents) within 3 months
• Hypersensitivity to parabens
• An infectious or inflammatory dermatosis of the face, scalp or forearms including acne rosacea
• A history of photodermatosis (example PMLE)
• Immunocompromised individuals
• Patients with auto-immune diseases
• Patients addicted to drugs or alcohol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral isotretinoin	oral isotretinoin	Twelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks.
tretinoin	Tretinoin	Twelve patients will be treated with 0,05% tretinoin cream applied on face and forearms at night and moisturizer broad-spectrum sunscreen twice a day.

Primary Outcome Measures

Name	Time	Method
Clinical, histological and immunohistochemical features before and after treatments	24 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life	24 weeks

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil