Clinical trial NCT06274320: Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment
Official title: 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%
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Actinic Keratoses
Keywords: actinic keratoses
Lipikar Urea 30%
Olsen grade
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2024-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in lesion response rate
timeFrame: from baseline to Day70
Secondary outcomes:
measure: Percentage change
timeFrame: from baseline to Day70
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: CentroDerm GmbH
Study officials:
affiliation: CentroDerm GmbH
name: Thomas Dirschka
role: PRINCIPAL_INVESTIGATOR
References: