Clinical trial · Interventional
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%
NCT06274320CI-TRIAL-00078045unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group A: holistic approach | Other | — | UNRESOLVED |
| Group B: Tolak® Standard of use | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: holistic approach
- description
- adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start
- interventionNames
- Other: Group A: holistic approach
- type
- ACTIVE_COMPARATOR
- label
- Group B: Tolak® Standard of use
- description
- adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start
- interventionNames
- Other: Group B: Tolak® Standard of use
Primary outcomes (1)
- measure
- Change in lesion response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.