Investigation of the Effect of Lipikar Baume AP+M
ConditionActinic Keratoses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentroDerm GmbH
About this trial
Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms.
It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria.
A total of 20 subjects will be enrolled.
The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application)).
Eligibility criteria
Qualifiers
Male, female, diverse persons (> 18yo) who are capable of giving consent
Female patients are eligible if the subject is not a woman of childbearing potential (WOCBP) or if she is postmenopausal (cessation of menstruation >12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, total hysterectomy)
Signed informed consent
Diagnosis of at least 4 actinic keratoses of the the forearm and/or back of the hand (each arm)
Disqualifiers
Known or documented intolerance to any of the ingredients of Lipikar Baume AP+M
Any planned AK treatment during the study
Treatment of actinic keratoses in the application area within the past 3 Months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)
Suspected invasive squamous cell cancer in the application area
Trial design
Treatments tested in this trial
- Lipikar Baume AP+M
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov