JOURNAL ONKOLOGIE – STUDIE

Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Noch nicht rekrutierend

NCT-Nummer:
NCT06274320

Studienbeginn:
April 2024

Letztes Update:
28.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Keratosis, Actinic, Keratosis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Cosmetique Active International

Collaborator:
-

Studienleiter

Thomas Dirschka
Principal Investigator
CentroDerm GmbH

Kontakt

Thomas Dirschka
Kontakt:
Phone: +49 2 02 / 629337-32
E-Mail: s.weber@centroderm.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

CentroDerm GmbH
Wuppertal
(Nordrhein-Westfalen)
Germany» Google-Maps

Studien-Informationen

Detailed Description:

Actinic keratoses (AK) are chronic skin changes usually induced by UV radiation. There are

numerous options to treat AK. Some of the most used field-directed therapies include topical

therapy with 5-fluorouracil (5-FU) cream and photodynamic therapy. However, the treatment

with 5-FU is not without side effects (erythema, pruritus, itching/burning, etc.). Therefore,

in daily clinical practice, cosmetic pre- and concomitant applications of cosmetics are often

recommended to increase the efficacy as well as the tolerability of Tolak®.

The aim of this randomized, evaluator blinded, controlled parallel group study conducted in

compliance with the 2013 version of the Declaration of Helsinki is to determine whether and

how the application of cosmetics leads to an influence on the microbiome of AK.

Statistical method: The variables will be analyzed by using the Cochran-Mantel-Haenszel (CMH)

statistic, after ridit transformation with the row mean difference statistics, testing the

hypothesis of equality. Each test will be two-sided, at the 0.050 significance level.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Studien-Rationale

Primary outcome:

1. Change in lesion response rate (Time Frame - from baseline to Day70):
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.

Secondary outcome:

1. Percentage change (Time Frame - from baseline to Day70):
The lesion complete response rate is defined as the percentage of pre-existing and treated lesions at Baseline that are assessed as clear (complete disappearance of the lesion, visually and by palpation).

Studien-Arme

Active Comparator: Group A: holistic approach
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
Active Comparator: Group B: Tolak® Standard of use
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

Geprüfte Regime

Group A: holistic approach:
2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment (once daily in the evening)
Group B: Tolak® Standard of use:
4-week Tolak® alone treatment (once daily in the evening)

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!