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Trial Title:
Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment
NCT ID:
NCT06274320
Condition:
Actinic Keratoses
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Conditions: Keywords:
actinic keratoses
Lipikar Urea 30%
Olsen grade
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Group A: holistic approach
Description:
2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment
(once daily in the evening)
Arm group label:
Group A: holistic approach
Intervention type:
Other
Intervention name:
Group B: Tolak® Standard of use
Description:
4-week Tolak® alone treatment (once daily in the evening)
Arm group label:
Group B: Tolak® Standard of use
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
CentroDerm GmbH
Address:
City:
Wuppertal
Country:
Germany
Status:
Recruiting
Start date:
April 5, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Cosmetique Active International
Agency class:
Industry
Source:
Cosmetique Active International
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06274320
