NCT06274320

Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment

Investigation of the Effect of a 2 Weeks Lipikar Urea 30% Application Preceding a Planned Topical 5-FU 4% Actinic Keratoses Treatment on Efficacy of 5-FU 4%

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment.

Detailed description

Actinic keratoses (AK) are chronic skin changes usually induced by UV radiation. There are numerous options to treat AK. Some of the most used field-directed therapies include topical therapy with 5-fluorouracil (5-FU) cream and photodynamic therapy. However, the treatment with 5-FU is not without side effects (erythema, pruritus, itching/burning, etc.). Therefore, in daily clinical practice, cosmetic pre- and concomitant applications of cosmetics are often recommended to increase the efficacy as well as the tolerability of Tolak®. The aim of this randomized, evaluator blinded, controlled parallel group study conducted in compliance with the 2013 version of the Declaration of Helsinki is to determine whether and how the application of cosmetics leads to an influence on the microbiome of AK. Statistical method: The variables will be analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. Each test will be two-sided, at the 0.050 significance level.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
OTHER	Group A: holistic approach	2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment (once daily in the evening)
OTHER	Group B: Tolak® Standard of use	4-week Tolak® alone treatment (once daily in the evening)

Timeline

• Start date: 2024-04-05
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-02-23
• Last updated: 2024-06-18

Locations

1 site across 1 country: Germany