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%

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.

Study Overview

• Status: Recruiting
• Conditions: Actinic Keratoses
• Intervention / Treatment: Other: Group A: holistic approach; Other: Group B: Tolak® Standard of use

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Dirschka; Phone Number: +49 2 02 / 629337-32; Email: s.weber@centroderm.de

Study Locations

• Germany
  • Wuppertal, Germany
    • Recruiting
    • CentroDerm GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group B: Tolak® Standard of use; 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	Other: Group B: Tolak® Standard of use; 4-week Tolak® alone treatment (once daily in the evening)
Experimental: Group A: holistic approach; 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	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lesion response rate	It is defined as the number of completely responding lesions divided by the total number of treated lesions in each field. Complete lesion response is defined as complete disappearance of the lesion both by palpation and visual.	from baseline to Day70

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change	The lesion complete response rate is defined as the percentage of pre-existing and treated lesions at Baseline that are assessed as clear (complete disappearance of the lesion, visually and by palpation).	from baseline to Day70

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Principal Investigator: Thomas Dirschka, CentroDerm GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: actinic keratoses; Olsen grade; Lipikar Urea 30%
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: LRP22002 LIPIKAR UREA 30%

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No