Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment

Actinic Keratoses Clinical Trial

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%

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06274320
• Other study ID #: LRP22002 LIPIKAR UREA 30%
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Cosmetique Active International
• Contact: Thomas Dirschka
• Phone: +49 2 02 / 629337-32
• Email: s.weber[@]centroderm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

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)
• Group B: Tolak® Standard of use
4-week Tolak® alone treatment (once daily in the evening)

Locations

Country	Name	City	State
Germany	CentroDerm GmbH	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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