Using Lipikar Urea 30% to improve treatment for actinic keratoses
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 testing if using Lipikar Urea 30% along with Tolak® can help adults with actinic keratoses on their scalp feel better and look better compared to just using Tolak® alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cosmetique Active International Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Wuppertal) |
| Trial ID | NCT06274320 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and tolerability of a holistic management approach using Lipikar Urea 30% in conjunction with Tolak® treatment for actinic keratoses on the scalp. Conducted in Germany, it involves adult participants with grade I or II lesions who meet specific inclusion criteria. The study aims to assess how the application of cosmetics may influence the microbiome of actinic keratoses and improve cosmetic outcomes. Participants are randomly assigned to either a holistic approach or standard treatment with Tolak®.
Who should consider this trial
Good fit: Ideal candidates are adults with at least four non-hypertrophic, non-hyperkeratotic actinic keratosis lesions on the scalp.
Not a fit: Patients with known intolerance to the ingredients of Tolak® or Lipikar Urea 30%, or those who have received recent treatment in the area, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the efficacy and tolerability of actinic keratoses treatments, leading to better patient outcomes.
How similar studies have performed: While there are various treatments for actinic keratoses, the specific combination of Lipikar Urea 30% with Tolak® is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wuppertal
- CentroDerm GmbH — Wuppertal, Germany (Recruiting)
Study contacts
- Principal investigator: Thomas Dirschka — CentroDerm GmbH
- Study coordinator: Thomas Dirschka
- Email: s.weber@centroderm.de
- Phone: +49 2 02 / 629337-32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.