Actinic Keratosis Clinical Trials

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

Status: Recruiting
Location: See location...
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• the study participant is in good general condition for his or her age and does not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study

Locations
Other Locations
Germany
CentroDerm
RECRUITING
Wuppertal
Contact Information
Primary
Thomas Dirschka, Prof. Dr. med.
T.dirschka@centroderm.de
+49(0)20262933736
Backup
Marcus Kuchner, Dr. med.
m.kuchner@centroderm.de
+49(0)20262933763
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: Thomas Dirschka

This content was sourced from clinicaltrials.gov