Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage
June 7, 2010 updated by: Federal University of São Paulo
A Clinical, Laboratorial and Quality of Life Study to Evaluate the Efficacy and Safety of Oral Isotretinoin in the Treatment of Cutaneous Photodamage
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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SP
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Sao Paulo, SP, Brazil, 04022000
- Federal University of São Paulo
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: oral isotretinoin
Twelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks.
|
one 20.0 mg capsule, once a day, every other day, during 24 weeks
Other Names:
|
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Active Comparator: tretinoin
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.
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0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinical, histological and immunohistochemical features before and after treatments
Time Frame: 24 weeks
|
24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life
Time Frame: 24 weeks
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24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edileia Bagatin, MD, PhD, Federal University of Sao Paulo, Brazil
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Anticipated)
August 1, 2010
Study Registration Dates
First Submitted
February 11, 2009
First Submitted That Met QC Criteria
February 11, 2009
First Posted (Estimate)
February 12, 2009
Study Record Updates
Last Update Posted (Estimate)
June 8, 2010
Last Update Submitted That Met QC Criteria
June 7, 2010
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNICCO
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