Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

NCT ID: NCT00842907

Last Updated: 2010-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-08-31

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.

Conditions

Photodamage; Photoaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

oral isotretinoin

Twelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks.

Group Type: ACTIVE_COMPARATOR

oral isotretinoin

Intervention Type: DRUG

one 20.0 mg capsule, once a day, every other day, during 24 weeks

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.

Group Type: ACTIVE_COMPARATOR

Tretinoin

Intervention Type: DRUG

0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks

Interventions

oral isotretinoin

one 20.0 mg capsule, once a day, every other day, during 24 weeks

Intervention Type: DRUG

Tretinoin

0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks

Intervention Type: DRUG

Other Intervention Names

oral retinoid; topical retinoid; topical tretinoin; topical retinoic acid

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Federal University of Sao Paulo

Principal Investigators

Edileia Bagatin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Sao Paulo, Brazil

Locations

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

UNICCO

Identifier Type: -

Identifier Source: org_study_id