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Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00701740
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : August 15, 2018
Information provided by (Responsible Party):
Edileia Bagatin, Federal University of São Paulo

Brief Summary:
A clinical and histological randomized controlled phase II trial to evaluate the efficacy and safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A- 21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three months; B- 11 women received only same moisturizer/sunscreen.

Condition or disease Intervention/treatment Phase
Photoaging Epidermal p53 Expression Drug: oral isotretinoin and Mexoryl SX / XL Drug: Mexoryl XL / SX Phase 2

Detailed Description:

Clinical assessment ranging from -2=very bad to +2=very good for all patients. Also, profilometry, corneometer and skin elasticity tests in periocular regions and left forearm; skin biopsy on left forearm before/after treatment in B and in 10 randomly selected patients from A. Microscopic evaluation of corneal layer and epidermal thickness, dermal elastosis, new collagen and p53 epidermal expression performed by quantitative digital image analysis. Blind evaluations (group/time) conducted by two independent observers.

Clinical evaluation results showed no alterations (0) or slight improvement (+1) for all patients; profilometry, corneometer and skin elasticity measurements presented a significant difference in pre and post treatment values (p=0,001 to 0,028) with no differences between A/B. Regarding histological findings and p53 expression no previous differences between groups before the treatment were observed (p>0,1).Quantitative microscopic digital analysis demonstrated no differences between groups at the end of the study for the majority of variables. However, slight but significant difference between A/B subjects was found for p53 with major expression reduction for those treated with oral isotretinoin [0,66±0,31 vs 0,94±0,34 respectively (p=0,04)]. The main side effects were cheilitis in 15 patients (75%) and xerophthalmia in 5 (25%). No significant alterations occurred in biochemical tests.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomized Controlled Trial to Evaluate the Clinical and Histological Effects of Oral Isotretinoin for the Treatment of Photoaging on Face and Forearms
Study Start Date : July 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A
A - 21 subjects were treated 20mg isotretinoin 3/week plus moisturizer and sunscreen,for three months; 10 randomly selected were submitted to skin biopsies before and after the end of treatment
Drug: oral isotretinoin and Mexoryl SX / XL
20mg, 3/week,continuously for three months
Other Names:
  • isotretinoin
  • mexoryl

Active Comparator: B
11 subjects received only the same moisturizer/sunscreen
Drug: Mexoryl XL / SX
11 subjects used only the same moisturizer and SPF 60 sunscreen
Other Name: mexoryl

Primary Outcome Measures :
  1. histological findings [ Time Frame: before and after 3 months ]

Secondary Outcome Measures :
  1. laboratory tests [ Time Frame: before, after 1 and 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • menopausal or sterilized women

Exclusion Criteria:

  • woman at risk of pregnancy, with alterations on liver function or lipid profile

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 identifier (NCT number): NCT00701740

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Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04023-900
Sponsors and Collaborators
Federal University of São Paulo
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Principal Investigator: Edileia Bagatin, MD, PHD Federal University of Sao Paulo
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Responsible Party: Edileia Bagatin, Federal University of São Paulo Identifier: NCT00701740    
Other Study ID Numbers: UNIFESP
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Keywords provided by Edileia Bagatin, Federal University of São Paulo:
digital analysis
Additional relevant MeSH terms:
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Skin Diseases
Terephthalylidene dicamphor sulfonic acid
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs