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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00701740
First received: June 18, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

June 18, 2008
June 18, 2008
July 2007
January 2008   (final data collection date for primary outcome measure)
histological findings [ Time Frame: before and after 3 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
laboratory tests [ Time Frame: before, after 1 and 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial
Phase II Randomized Controlled Trial to Evaluate the Clinical and Histological Effects of Oral Isotretinoin for the Treatment of Photoaging on Face and Forearms

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Photoaging
  • Epidermal p53 Expression
  • Drug: oral isotretinoin and Mexoryl SX / XL
    20mg, 3/week,continuously for three months
    Other Names:
    • isotretinoin
    • mexoryl
  • Drug: Mexoryl XL / SX
    11 subjects used only the same moisturizer and SPF 60 sunscreen
    Other Name: mexoryl
  • 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
    Intervention: Drug: oral isotretinoin and Mexoryl SX / XL
  • Active Comparator: B
    11 subjects received only the same moisturizer/sunscreen
    Intervention: Drug: Mexoryl XL / SX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • menopausal or sterilized women

Exclusion Criteria:

  • woman at risk of pregnancy, with alterations on liver function or lipid profile
Female
40 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00701740
UNIFESP
Yes
Edileia Bagatin , MD, PHD, Federal University of Sao Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: Edileia Bagatin, MD, PHD Federal University of Sao Paulo
Federal University of São Paulo
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP