Investigation of the Effect of Lipikar Baume AP+M

Last updated: October 17, 2024
Sponsor: CentroDerm GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Keratoses

Treatment

Lipikar Baume AP+M

Clinical Study ID

NCT06385340
CentroDerm_LRP22003
  • Ages > 18
  • All Genders

Study 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

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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Lipikar Baume AP+M
Phase:
Study Start date:
April 23, 2024
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • CentroDerm GmbH

    Wuppertal, NRW 42287
    Germany

    Active - Recruiting

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