Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

Photoaging Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00842907
• Other study ID #: UNICCO
• Status: Unknown status
• Phase: Phase 2
• First received: February 11, 2009
• Last updated: June 7, 2010
• Start date: May 2009
• Est. completion date: August 2010

Study information

• Verified date: April 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Photoaging
• Photodamage

Intervention

Drug:
• oral isotretinoin
one 20.0 mg capsule, once a day, every other day, during 24 weeks
• Tretinoin
0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical, histological and immunohistochemical features before and after treatments		24 weeks
Secondary	Quality of life		24 weeks