Photoaging Clinical Trial
Official title:
A Clinical, Laboratorial and Quality of Life Study to Evaluate the Efficacy and Safety of Oral Isotretinoin in the Treatment of Cutaneous Photodamage
Verified date | April 2009 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Unknown status |
Enrollment | 20 |
Est. completion date | August 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Sao Paulo | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical, histological and immunohistochemical features before and after treatments | 24 weeks | ||
Secondary | Quality of life | 24 weeks |
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