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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
  Purpose

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 Intervention Phase
Photoaging
Epidermal p53 Expression
 Drug: oral isotretinoin and Mexoryl SX / XL
Drug: Mexoryl XL / SX
 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: Phase II Randomized Controlled Trial to Evaluate the Clinical and Histological Effects of Oral Isotretinoin for the Treatment of Photoaging on Face and Forearms

Resource links provided by NLM:

MedlinePlus related topics: Sun Exposure
U.S. FDA Resources

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

Primary Outcome Measures:
  • histological findings [ Time Frame: before and after 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • laboratory tests [ Time Frame: before, after 1 and 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: July 2007
Study Completion Date: June 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • menopausal or sterilized women

Exclusion Criteria:

  • woman at risk of pregnancy, with alterations on liver function or lipid profile
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701740

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04023-900
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Edileia Bagatin, MD, PHD Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: Edileia Bagatin , MD, PHD, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00701740     History of Changes
Other Study ID Numbers: UNIFESP
Study First Received: June 18, 2008
Last Updated: June 18, 2008
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
photoaging
isotretinoin
profilometry
digital analysis

Additional relevant MeSH terms:
Skin Diseases
Terephthalylidene dicamphor sulfonic acid
Isotretinoin
Dermatologic Agents
Therapeutic Uses
 Pharmacologic Actions
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013