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Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00842907
First received: February 11, 2009
Last updated: June 7, 2010
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Photodamage
Photoaging
 Drug: oral isotretinoin
Drug: Tretinoin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Clinical, histological and immunohistochemical features before and after treatments [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral isotretinoin
Twelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks.
 Drug: oral isotretinoin
one 20.0 mg capsule, once a day, every other day, during 24 weeks
Other Name: oral retinoid
Active Comparator: 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.
 Drug: Tretinoin
0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks
Other Names:
  • topical retinoid
  • topical tretinoin
  • topical retinoic acid

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842907

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04022000
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Edileia Bagatin, MD, PhD Federal University of Sao Paulo, Brazil
  More Information

No publications provided

Responsible Party: Edileia Bagatin, MD, PhD, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00842907     History of Changes
Other Study ID Numbers: UNICCO
Study First Received: February 11, 2009
Last Updated: June 7, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Brazil
isotretinoin
photodamage
photoaging

Additional relevant MeSH terms:
Isotretinoin
Tretinoin
Dermatologic Agents
Therapeutic Uses
 Pharmacologic Actions
Antineoplastic Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on May 23, 2013