Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

• Status: Unknown status
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Federal University of São Paulo
• Treatments: Isotretinoin; Tretinoin

Criteria

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