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%
Cosmetique Active International
100 participants
Apr 5, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria4
- 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
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Interventions
2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment (once daily in the evening)
4-week Tolak® alone treatment (once daily in the evening)
Locations(1)
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NCT06274320