Status:
UNKNOWN
Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage
Lead Sponsor:
Federal University of São Paulo
Conditions:
Photodamage
Photoaging
Eligibility:
All Genders
50-75 years
Phase:
PHASE2
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 ...
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 forear...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00842907
Start Date
May 1 2009
End Date
August 1 2010
Last Update
June 8 2010
Active Locations (1)
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1
Federal University of Sao Paulo
São Paulo, São Paulo, Brazil, 04022000