Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

NCT00842907 | Unknown Phase 2 DMC

• 1 other identifier: UNICCO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Photodamage; Photoaging

Keywords

Brazil; isotretinoin; photodamage; photoaging

Outcome Measures

Primary Outcomes (1)

• Clinical, histological and immunohistochemical features before and after treatments

  24 weeks

Secondary Outcomes (1)

• Quality of life

  24 weeks

Study Arms (2)

oral isotretinoin

ACTIVE COMPARATOR

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

Drug: oral isotretinoin

tretinoin

ACTIVE COMPARATOR

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

Interventions

oral isotretinoin DRUG

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

Also known as: oral retinoid

oral isotretinoin

Tretinoin DRUG

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

Also known as: topical retinoid, topical tretinoin, topical retinoic acid

tretinoin

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients of child bearing potential
• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04022000, Brazil

Location

MeSH Terms

Interventions

Isotretinoin; Retinoids; Tretinoin

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Vitamin A; Diterpenes

Study Officials

• Edileia Bagatin, MD, PhD

  Federal University of Sao Paulo, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: August 1, 2010
• Last Updated: June 8, 2010

Record last verified: 2009-04

Locations

BR (1)