Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment

NCT06274320 | Recruiting

• 1 other identifier: LRP22002 LIPIKAR UREA 30%
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment.

Conditions

Actinic Keratoses

Keywords

actinic keratoses; Lipikar Urea 30%; Olsen grade

Outcome Measures

Primary Outcomes (1)

• Change in lesion response rate

  It is defined as the number of completely responding lesions divided by the total number of treated lesions in each field. Complete lesion response is defined as complete disappearance of the lesion both by palpation and visual.

  from baseline to Day70

Secondary Outcomes (1)

• Percentage change

  from baseline to Day70

Study Arms (2)

Group A: holistic approach

EXPERIMENTAL

adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start

Other: Group A: holistic approach

Group B: Tolak® Standard of use

ACTIVE COMPARATOR

adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start

Other: Group B: Tolak® Standard of use

Interventions

Group A: holistic approach OTHER

2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment (once daily in the evening)

Group A: holistic approach

Group B: Tolak® Standard of use OTHER

4-week Tolak® alone treatment (once daily in the evening)

Group B: Tolak® Standard of use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of at least 4 non-hypertrophic, non-hyperkeratotic actinic keratosis of the the scalp
• planned treatment of actinic keratoses of the scalp with Tolak®
• Olsen grade I or II

You may not qualify if:

• known or documented intolerance to any of the ingredients of Tolak® or Lipikar Urea 30%
• treatment of actinic keratoses in the treatment area within the past 3 months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)
• suspected invasive squamous cell cancer in the treatment area
• chronic wounds, erosions, pre-existing inflamed or infected skin with disruption of the epidermal barrier in the treatment area current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CentroDerm GmbH

Wuppertal, 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

  CentroDerm GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Dirschka

CONTACT

+49 2 02 / 629337-32; s.weber@centroderm.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 23, 2024
• Study Start: April 5, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

DE (1)