Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment
ConditionActinic Keratoses
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Group A: holistic approach
Other intervention2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment (once daily in the evening)
Group B: Tolak® Standard of use
Other intervention4-week Tolak® alone treatment (once daily in the evening)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group A: holistic approachExperimental treatment 1 intervention
Group B: Group B: Tolak® Standard of useActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in lesion response rate
It is defined as the number of completely responding lesions divided by the total number of treated lesions in each field. Complete lesion response is defined as complete disappearance of the lesion both by palpation and visual.
Time frame
from baseline to Day70Secondary outcomes
1
Percentage change
The lesion complete response rate is defined as the percentage of pre-existing and treated lesions at Baseline that are assessed as clear (complete disappearance of the lesion, visually and by palpation).
Time frame
from baseline to Day70Sponsors and contacts
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Source ClinicalTrials.gov