Investigation of the Effect of Lipikar Baume AP+M

NCT06385340 | Recruiting

• 1 other identifier: CentroDerm_LRP22003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)).

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (5)

• Skin hydration measured by Corneometrie

  Corneometer® (Courage + Khazaka electronics GmbH, Cologne, Germany) is used to assess skin hydration after 28 days. The Corneometer® measures in arbitrary units from 0 (no water) - 120 (on water). The units are referred to as "Corneometer® units". In total there will be 3 measurements at each point (Actinic keratosis, perilesional, never by actinic keratosis affected skin/healthy). The average of the 3 measurements is calculated and day 0 and day 28 are compared.

  Day 28

• Transepidermal water loss measured by Tewameter®

  Transepidermal water loss (in g/m2/h - TEWL) measured by Tewameter® (Courage + Khazaka electronics GmbH, Cologne, Germany). 3 measurements at each arm und lesion will be taken (Actinic keratosis, perilesional and never by actinic keratosis affected skin). The average of the 3 measurements is calculated and day 0 and day 28 are compared.

  Day 28

• Aktinic keratosis area and severity index (AKASI)

  The AKASI is a standardized tool for the clinically adequate assessment of larger areas (1). The area, distribution, erythema, and thickening of actinic keratoses are evaluated according to Dirschka et al. and a score is calculated. The score is between 0-18. Average values of study participants of each study group will be compared (day 0, day 28). 1\. Dirschka T, Pellacani G, Micali G, Malvehy J, Stratigos AJ, Casari A, et al. A proposed scoring system for assessing the severity of actinic keratosis on the head: actinic keratosis area and severity index. J Eur Acad Dermatol Venereol. 2017;31(8):1295-302.

  Day 28

• S. aureus colonization and S. epidermidis colonization (application area)

  S. aureus colonization and S. epidermidis colonization is assessed after 28 days by skin swabs and qPCR. Quantification is based on fluorescence measurements taken in real time during a PCR cycle. Fluorescence increases in proportion to the amount of PCR product. At the end of a run (consisting of several cycles), quantification is performed in the exponential phase of the PCR using the fluorescence signals obtained. Mean Ct values (cycle threshold) of the study groups are given for qPCR.

  Day 28

• Subjects's skin aspect

  The investigator will assess the subject's skin aspect on the following signs or symptoms: scarring, atrophy, induration, redness or change in pigmentation. The Score is between 0 (poor) and 3 (Excellent). The investigator will assess the subjects skin aspect at day 28 for all lesions, that have disappeared. An anverage of the score is calculated for all lesions in each study group.

  Day 28

Secondary Outcomes (7)

• Absolute lesion count by application site

  Day 28

• Olsen Grade evaluation: percentage of lesion with improvement at least 1 grade at D28 by application site

  Day 28

• Number of new lesions on application area over the study period by application site

  Day 28

• Symptom severity score: percentage across individual scores at each visit by application site

  Day 28

• modified Treatment Satisfaction Questionnaire for Medication-9 (mTSQM-9)

  Day 28

Study Arms (2)

Lipikar Baume AP+M

OTHER

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

Other: Lipikar Baume AP+M

no intervention

NO INTERVENTION

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

Interventions

Lipikar Baume AP+M OTHER

• 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

Lipikar Baume AP+M

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 \>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

You may not qualify 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, 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.)
• 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

Sponsors & Collaborators

• CentroDerm GmbH: lead

Study Sites (1)

CentroDerm GmbH

Wuppertal, North Rhine-Westphalia, 42287, Germany

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thomas Dirschka, Prof. Dr.

  CentroDerm GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Dirschka, Prof. Dr.

CONTACT

+49 (0) 202 - 62 933 70; info@centroderm.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 26, 2024
• Study Start: April 23, 2024
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

DE (1)