Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCosmetique Active International

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Group A: holistic approach
  • Group B: Tolak® Standard of use

Treatment groups

100 Participants
are divided into 2 treatment groups