Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical, Laboratorial and Quality of Life Study to Evaluate the Efficacy and Safety of Oral Isotretinoin in the Treatment of Cutaneous Photodamage

Conditions
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Photodamage, Photoaging

Intervention / Treatment
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* Drug: oral isotretinoin
* Drug: Tretinoin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral isotretinoin<br>Twelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks. | Drug: oral isotretinoin<br>* one 20.0 mg capsule, once a day, every other day, during 24 weeks<br>* Other names: oral retinoid;|
| Active Comparator: tretinoin<br>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. | Drug: Tretinoin<br>* 0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks<br>* Other names: topical retinoic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical, histological and immunohistochemical features before and after treatments |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brazil, isotretinoin, photodamage, photoaging