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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2vmk27
Enrollment
Unknown
Registered
2016-01-04
Start date
2013-06-21
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

actinic keratosis, nonthrombocytopenic purpura, melanin hyperpigmentation, cutis laxa senilis, leukoderma, skin changes due to chronic exposure to nonionizing radiation

Interventions

24 research's subjects will be treated with 0.05% retinoic acid in the extensor surface of a forearm 3 alternate nights a week, and will be submitted to 8 series and biweekly peels of retinoic acid at
Drug
Q20.040
D02.455.326.271.665.202.495.818.500

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Unidade de Cosmiatria, Cirurgia e Oncologia do Departamento de Dermatologia da Universidade Federal de São Paulo
Collaborator
Instituto de Ciências Ambientais, Químicas e Farmacêuticas da Universidade Federal de São Paulo
Collaborator

Eligibility

Age
60 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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%).

Secondary

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

Countries

Brazil

Contacts

Public ContactJuliana Sumita

Universidade Federal de São Paulo

juliana.sumita@gmail.com55 (11) 55497525

Outcome results

None listed

Source: REBEC (via WHO ICTRP)