Clinical trial NCT06385340: Investigation of the Effect of Lipikar Baume AP+M
Official title: Investigation of the Effect of Lipikar Baume AP+M on Skin Barrier, Microbiome and AKASI of Participants with Actinic Keratoses and Field Cancerization of the Forearms and Hands
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Actinic Keratoses
Lead sponsor: CentroDerm GmbH
Sponsor class: NETWORK
First posted: 2024-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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) 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)
* 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 not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study

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 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

Primary outcomes:
measure: Skin hydration measured by Corneometrie
timeFrame: Day 28
measure: Transepidermal water loss measured by Tewameter®
timeFrame: Day 28
measure: Aktinic keratosis area and severity index (AKASI)
timeFrame: Day 28
measure: S. aureus colonization and S. epidermidis colonization (application area)
timeFrame: Day 28
measure: Subjects's skin aspect
timeFrame: Day 28
Secondary outcomes:
measure: Absolute lesion count by application site
timeFrame: Day 28
measure: Olsen Grade evaluation: percentage of lesion with improvement at least 1 grade at D28 by application site
timeFrame: Day 28
measure: Number of new lesions on application area over the study period by application site
timeFrame: Day 28
measure: Symptom severity score: percentage across individual scores at each visit by application site
timeFrame: Day 28
measure: modified Treatment Satisfaction Questionnaire for Medication-9 (mTSQM-9)
timeFrame: Day 28
measure: Compliance (percentage of subjects using topical agents at all intended days, 90% of days or 75% of days)
timeFrame: Day 28
measure: Pictures at all time points
timeFrame: Day 28
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: CentroDerm GmbH
state: NRW
Study officials:
affiliation: CentroDerm GmbH
name: Thomas Dirschka, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: