Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06274320

Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment

Led by Cosmetique Active International · Updated on 2024-06-18

100

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of at least 4 non-hypertrophic, non-hyperkeratotic actinic keratosis lesions on the scalp
  • Planned treatment of actinic keratoses on the scalp with Tolak4
  • Olsen grade I or II actinic keratosis lesions
Not Eligible

You will not qualify if you...

  • Known or documented intolerance to any ingredients of Tolak4 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)
  • Suspected invasive squamous cell cancer in the treatment area
  • Chronic wounds, erosions, or inflamed/infected skin disrupting the epidermal barrier in the treatment area currently or within the last 8 weeks
  • Given systemic cancer medication or systemic treatment with 5-Fluorouracil

AI-Screening

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Trial Site Locations

Total: 1 location

1

CentroDerm GmbH

Wuppertal, Germany

Actively Recruiting

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Research Team

T

Thomas Dirschka

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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