Phase
Condition
Keratoses
Treatment
Lipikar Baume AP+M
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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) orsurgically sterile (bilateral tubal ligation, bilateral oophorectomy, totalhysterectomy)
Signed informed consent
Diagnosis of at least 4 actinic keratoses of the the forearm and/or back of the hand (each arm)
Olsen grade I, II and/or III
Subjects with similar severity and number of AKs on each side symmetrically
The study participant is in good general condition for his or her age and does notcurrently have any active diseases that, in the opinion of the investigator, justifyexclusion from the study
Exclusion
Exclusion Criteria:
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
Chronic wounds, erosions, pre-existing infected skin or inflammation which, in theopinion of the investigator, are in need of treatment other than the study product
Suspected non-compliance
Current or within the last 8 weeks given systemic cancer medication or systemictreatment with 5-Fluorouracil
Any systemic immunosuppressant given within the 8 weeks prior to the study (e.g.systemic prednisolone, azathioprine etc.)
Locally applied retinoids, steroids, or other prescribed externals in the 4 weeksprior to the start of the study that, in the opinion of the study physician,necessitate exclusion
Products containing glycolic or alpha-hydroxy acids applied locally in theapplication area in the last 4 weeks
Participation in another clinical trial
Participation in a clinical study within the last 30 days
Family members or colleagues of the investigator
Participant is in a position or has a relationship with the investigator thatpresents a potential conflict of interest
Study Design
Connect with a study center
CentroDerm GmbH
Wuppertal, NRW 42287
GermanyActive - Recruiting
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