This trial is active, not recruiting.

Conditions photodamage, photoaging
Treatments oral isotretinoin, tretinoin
Phase phase 2
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
Twelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks.
oral isotretinoin oral retinoid
one 20.0 mg capsule, once a day, every other day, during 24 weeks
(Active Comparator)
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.
tretinoin topical retinoid
0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks

Primary Outcomes

Clinical, histological and immunohistochemical features before and after treatments
time frame: 24 weeks

Secondary Outcomes

Quality of life
time frame: 24 weeks

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.