Actinic Keratoses
Conditions
Keywords
actinic keratoses, Lipikar Urea 30%, Olsen grade
Brief summary
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.
Detailed description
Actinic keratoses (AK) are chronic skin changes usually induced by UV radiation. There are numerous options to treat AK. Some of the most used field-directed therapies include topical therapy with 5-fluorouracil (5-FU) cream and photodynamic therapy. However, the treatment with 5-FU is not without side effects (erythema, pruritus, itching/burning, etc.). Therefore, in daily clinical practice, cosmetic pre- and concomitant applications of cosmetics are often recommended to increase the efficacy as well as the tolerability of Tolak®. The aim of this randomized, evaluator blinded, controlled parallel group study conducted in compliance with the 2013 version of the Declaration of Helsinki is to determine whether and how the application of cosmetics leads to an influence on the microbiome of AK. Statistical method: The variables will be analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. Each test will be two-sided, at the 0.050 significance level.
Interventions
OTHERGroup A: holistic approach
2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment (once daily in the evening)
OTHERGroup B: Tolak® Standard of use
4-week Tolak® alone treatment (once daily in the evening)
Sponsors
Cosmetique Active International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lesion response rate | from baseline to Day70 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change | from baseline to Day70 | 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). |
Countries
Germany
Contacts
Primary ContactThomas Dirschka
Outcome results
None listed