Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment

Cosmetique Active

Status: Enrolling

Conditions: Actinic Keratoses

Treatments: Other: Group A: holistic approach; Other: Group B: Tolak® Standard of use

Study type: Interventional

Funder types: Industry

Identifiers

NCT06274320

LRP22002 LIPIKAR UREA 30%

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• diagnosis of at least 4 non-hypertrophic, non-hyperkeratotic actinic keratosis of the the scalp
• planned treatment of actinic keratoses of the scalp with Tolak®
• Olsen grade I or II

Exclusion criteria

• known or documented intolerance to any of the ingredients of Tolak® or Lipikar Urea 30%
• treatment of actinic keratoses in the treatment area within the past 3 months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)
• suspected invasive squamous cell cancer in the treatment area
• chronic wounds, erosions, pre-existing inflamed or infected skin with disruption of the epidermal barrier in the treatment area current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Group A: holistic approach

Experimental group

Description:

adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start

Treatment:

Other: Group A: holistic approach

Group B: Tolak® Standard of use

Active Comparator group

Description:

adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start

Treatment:

Other: Group B: Tolak® Standard of use