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Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage

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ClinicalTrials.gov Identifier: NCT00842907
Recruitment Status : Unknown
Verified April 2009 by Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2009
Last Update Posted : June 8, 2010
Sponsor:
Information provided by:
Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Photodamage Photoaging Drug: oral isotretinoin Drug: Tretinoin Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : May 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Clinical, histological and immunohistochemical features before and after treatments [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Edileia Bagatin, MD, PhD, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00842907     History of Changes
Other Study ID Numbers: UNICCO
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: April 2009

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

Additional relevant MeSH terms:
Tretinoin
Isotretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents