Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage
Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Photodamage; Photoaging
Intervention: oral isotretinoin (Drug); Tretinoin (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s): Edileia Bagatin, MD, PhD, Principal Investigator, Affiliation: Federal University of Sao Paulo, Brazil
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical, histological and immunohistochemical features before and after treatments
Secondary outcome: Quality of life
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 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.
Eligibility
Minimum age: 50 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Federal University of Sao Paulo, Sao Paulo, SP 04022000, Brazil
Additional Information
Starting date: May 2009
Last updated: June 7, 2010
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