Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment

Last updated: June 14, 2024
Sponsor: Cosmetique Active International
Overall Status: Active - Recruiting

Phase

N/A

Condition

Keratoses

Treatment

Group A: holistic approach

Group B: Tolak® Standard of use

Clinical Study ID

NCT06274320
LRP22002 LIPIKAR UREA 30%
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • diagnosis of at least 4 non-hypertrophic, non-hyperkeratotic actinic keratosis ofthe the scalp

  • planned treatment of actinic keratoses of the scalp with Tolak®

  • Olsen grade I or II

Exclusion

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 ofthe epidermal barrier in the treatment area current or within the last 8 weeks givensystemic cancer medication or systemic treatment with 5-Fluorouracil

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Group A: holistic approach
Phase:
Study Start date:
April 05, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • CentroDerm GmbH

    Wuppertal,
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.