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Recruiting NCT06385340

Investigation of the Effect of Lipikar Baume AP+M

No phase Interventional Actinic Keratoses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lipikar Baume AP+M.
Who it may be relevant to
Registry conditions: Actinic Keratoses. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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)).

Interventions

  • Other Lipikar Baume AP+M
    • Lipikar Baume AP+M Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme

Primary outcome measures

  • Skin hydration measured by Corneometrie [Time frame: Day 28]
  • Transepidermal water loss measured by Tewameter® [Time frame: Day 28]
  • Aktinic keratosis area and severity index (AKASI) [Time frame: Day 28]
  • S. aureus colonization and S. epidermidis colonization (application area) [Time frame: Day 28]
  • Subjects's skin aspect [Time frame: Day 28]
Secondary outcome measures (7)
  • Absolute lesion count by application site [Time frame: Day 28]
  • Olsen Grade evaluation: percentage of lesion with improvement at least 1 grade at D28 by application site [Time frame: Day 28]
  • Number of new lesions on application area over the study period by application site [Time frame: Day 28]
  • Symptom severity score: percentage across individual scores at each visit by application site [Time frame: Day 28]
  • modified Treatment Satisfaction Questionnaire for Medication-9 (mTSQM-9) [Time frame: Day 28]
  • Compliance (percentage of subjects using topical agents at all intended days, 90% of days or 75% of days) [Time frame: Day 28]
  • Pictures at all time points [Time frame: Day 28]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Germany · 1 center
  • CentroDerm GmbH — Wuppertal

Identifiers

NCT: NCT06385340 · CentroDerm_LRP22003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗