Stability Evaluation and Clinical-Laboratory Study to Verify and Compare Efficay and Safety of Retinoic Acid Cream 0.05% and 5% in Superficial Peels

Not Applicable

• Conditions: actinic keratosis, nonthrombocytopenic purpura, melanin hyperpigmentation, cutis laxa senilis, leukoderma, skin changes due to chronic exposure to nonionizing radiation; L57.0; D69.2; L81.4; L57.4; L81.5; L57.8

• Registration Number: RBR-2vmk27
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Healthy women that past menopause and were not hormone replacement of any kind, over the age of 60; phototypes II and III according to Fitzpatrick's classification (1988) (Appendix 2); presence of superficial actinic keratoses and multiple through proposed score on the scale of Guimarães (2015) (Appendix 3); agreement to avoid sun exposure throughout the study; agreement with the conditions of study, ability to understand and strictly follow the guidelines received, willingness to attend the regular review and signature of IC (Appendix 1).

Exclusion Criteria

Local treatment, except sunscreens, with tretinoin for at least 6 months, other retinoids, alpha-hydroxy acids, polyhydroxy acids, beta-hydroxy acids and ascorbic acid for at least 3 months; previous treatment with oral retinoid in the last 6 months; previous treatment with superficial chemical peels, microdermabrasion and laser non-ablative, for a period not exceeding three months; presence of infectious or inflammatory dermatoses in the upper limbs; chemotherapy in the last three months; clinical evidence of immunosuppression.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical improvement of photodamaged skin of the forearm, supported by additional tests (photographic scale, noninvasive assays, histological and immunohistochemical findings) after topical treatment with retinoic acid, but with a statistically significant difference between the two therapeutic models (0.05% vs. 5%).<br><br>

Secondary Outcome Measures

Name	Time	Method
Differences between the two tolerability therapeutic models (0.05% vs. 5%), evaluated clinically and by means of noninvasive tests (corneometry, for example).