Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage
This trial is active, not recruiting.
|Treatments||oral isotretinoin, tretinoin|
|Sponsor||Federal University of São Paulo|
|Start date||May 2009|
|End date||December 2009|
|Trial size||20 participants|
|Trial identifier||NCT00842907, UNICCO|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Clinical, histological and immunohistochemical features before and after treatments
time frame: 24 weeks
Quality of life
time frame: 24 weeks
Male or female participants from 50 years up to 75 years old.
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
|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|
|Principal investigator||Edileia Bagatin, MD, PhD|
|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.|
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