Actively Recruiting
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%
Led by Cosmetique Active International · Updated on 2024-06-18
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on adults with actinic keratoses (AK) lesions on the scalp, specifically grade I or II. It aims to evaluate how a holistic management approach using Tolak4 treatment affects treatment effectiveness, tolerability, and the cosmetic appearance of lesions. The study also investigates how cosmetic application influences the skin microbiome during AK treatment. The study compares two groups: one receiving a holistic approach involving 2 weeks of Lipikar Urea 30% applied once daily in the evening followed by 4 weeks of Tolak4 treatment once daily in the evening, and the other group receiving the standard 4-week Tolak4 treatment alone once daily in the evening. The study is randomized, evaluator-blinded, and controlled, adhering to ethical standards. Participants will be assessed from baseline through Day 70, with researchers measuring changes in lesion response rates and percentage changes in lesions. Evaluations include monitoring the skin's appearance, tolerability of treatments, and cosmetic outcomes. The study also uses statistical methods to analyze results and ensures that participants' safety and treatment effects are carefully observed throughout the study period.
CONDITIONS
Brief Title
Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of at least 4 non-hypertrophic, non-hyperkeratotic actinic keratosis lesions on the scalp
- Planned treatment of actinic keratoses of the scalp with Tolak4
- Olsen grade I or II actinic keratosis
You will not qualify if you...
- Known or documented intolerance to any ingredients of Tolak4 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)
- Suspected invasive squamous cell cancer in the treatment area
- Chronic wounds, erosions, or inflamed/infected skin with disrupted epidermal barrier in the treatment area currently or within the last 8 weeks
- Given systemic cancer medication or systemic treatment with 5-Fluorouracil
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants in Group A apply Lipikar Urea 30% once daily in the evening for 2 weeks before starting Tolak® treatment.
Daily application at home
Duration - 4 weeks
Participants receive Tolak® treatment once daily in the evening for 4 weeks. Group A receives this following the 2-week Lipikar Urea 30% application, while Group B receives Tolak® alone.
Daily application at home
Duration - Up to Day 70 from baseline
Participants are monitored for changes in lesion response rate and safety following the end of treatment.
1 to 2 visits depending on assessment schedule
Trial Site Locations
Total: 1 location
1
CentroDerm GmbH
Wuppertal, Germany
Actively Recruiting
Research Team
T
Thomas Dirschka
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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