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

Launched by THOMAS DIRSCHKA · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a cream called tirbanibulin for treating actinic keratosis (AK), which are rough patches on the skin caused by sun damage. The goal is to see how well tirbanibulin works in reducing these patches and to check for any side effects that might occur on the skin. Participants will have the cream applied to their skin and will have their condition monitored over time using special imaging techniques.

To join the study, participants need to be at least 18 years old and have at least one actinic keratosis on their scalp or face. Women who can become pregnant must meet certain criteria regarding their reproductive health. Participants should not have had recent treatments for AK or any other significant skin conditions in the area being treated. Those who qualify will receive the cream and will have regular check-ins to assess their skin's response. It's important to know that this study is not yet recruiting participants, so there will be more information available once it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.)
• • locally applied retinoids, steroids, or other prescribed externals in the 4 weeks prior to the start of the study in the treatment area that, in the opinion of the study physician, necessitate exclusion
• • 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
• • patient is in a position or has a relationship with the investigator that presents a potential conflict of interest