Clinical trial NCT00842907: Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Photodamage
Photoaging
Keywords: Brazil
isotretinoin
photodamage
photoaging
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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 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

Primary outcomes:
measure: Clinical, histological and immunohistochemical features before and after treatments
timeFrame: 24 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of Sao Paulo, Brazil
name: Edileia Bagatin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: