Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

NCT06648447 | Recruiting

• 1 other identifier: CentroDerm_TIR24001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to observe the influence of tirbanibulin on proliferation patterns of actinic keratoses (efficacy on proliferation score according to Schmitz et al.). For this purpose, tirbanibulin is applied in-label, proliferation is measured by LC-OCT at different time points and dermatohistopathology is performed (optionally) at the end. Local skin reactions to the product will also be recorded (tolerability).

Conditions

Actinic Keratosis (AK)

Keywords

actinic keratosis; klisyri; tirbanibulin; proliferating actinic keratosis; proliferating actinic keratoses; LC-OCT

Outcome Measures

Primary Outcomes (2)

• - Improvement of the PRO score of the marker lesion at D57 (LC-OCT) and/or clearance in LC-OCT of marker lesion at D57

  Measurement will be done by LC-OCT to detect the PRO Score of the actinic keratosis.

  70 days after inclusion (57 days after visit 2)

• assessment of local skin reaction grading scale at V2

  Assessment of the local skin reaction via a 4-point-likert scaled measurement of erythema, scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration

  14 days after baseline visit

Secondary Outcomes (5)

• Clinical clearance of marker lesion at visit 2

  14 days after baseline visit

• Clinical clearance of marker lesion at visit 3

  70 days after baseline

• Improvement of PRO Score at V2

  14 days after baseline

• LC-OCT clearance of marker lesion at V2

  14 days after baseline

• Histopathological clearance of marker lesion at V3

  70 days after baseline

Eligibility Criteria

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

Study Population

Patients from the medical office (Berufsausübungsgemeinschaft Prof. Dr. Dirschka und Priv.-Doz. Dr. Schmitz).

You may qualify if:

• male, female, diverse patients (\> 18yo) who are capable of giving consent
• female patients are eligible if the patient 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 1 non-hypertrophic, non-hyperkeratotic actinic keratosis of the scalp or face with Olsen Grade I and PRO II or III
• planned treatment of AK with Klisyri® before study start and indepently of the study

You may not qualify if:

• known or documented intolerance to any of the ingredients of Klisyri®
• any planned AK treatment other than Klisyri® in the treatment area
• 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
• suspected non-compliance
• current or within the last 8 weeks given systemic cancer medication
• any other topical treatment against actinic keratosis in the treatment area within the past 12 weeks
• any contraindication according to the Summary of Product Characteristics (SmPC) of Klisyri®
• 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 treatment area in the last 4 weeks
• chemical peelings in the treatment area in the last 4 weeks
• simultaneous participation in a clinical trial
• participation in a clinical study within the last 30 days
• family members or colleagues of the investigator or the investigational team or the CRO

Sponsors & Collaborators

• Thomas Dirschka: lead

Study Sites (1)

CentroDerm

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

Central Study Contacts

Thomas Dirschka, Prof. Dr. med.

CONTACT

+49(0)20262933736; T.dirschka@centroderm.de

Marcus Kuchner, Dr. med.

CONTACT

+49(0)20262933763; m.kuchner@centroderm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 70 Days
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: October 22, 2024
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)