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New treatment option for Actinic Keratoses
Official title Investigation of the Effect of Lipikar Baume AP+M
ClinicalTrials.gov ID: NCT06385340
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Suspected invasive squamous cell cancer in the application area
- Chronic wounds, erosions, pre-existing infected skin or inflammation which, in the opinion of the investigator, are in need of treatment other than...
- Suspected non-compliance
See the full eligibility 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) or surgically sterile (bilateral tubal ligation, bilateral...
- 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
- people 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 not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study
- 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 the opinion 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 systemic treatment 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 weeks prior 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 the application 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 that presents a potential conflict of interest
The study team makes the final eligibility decision.
Where it's taking place
- Wuppertal, North Rhine-Westphalia, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuppertal, North Rhine-Westphalia, Germany. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.