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Interventional, monocentric, national, internal placebo-controlled, prospective pilot study, consisting of two parts, A (single-blinded) and B (open) to assess Efficacy of Tirbanibulin for the treatment of AK on the back of the hand. In part A, eligible subjects receive Tirbanibulin on the left hand and placebo on the right hand for 5 d in a single-blinded manner. Safety and efficacy are assessed at day 8 (± 1 d) (3 days after the end of treatment (EoT+3) and day 57 (± 7 d) after the start of the treatment. Pictures will be taken at baseline, 8 d and 57 d (± 7 d) as per protocol and optional during unscheduled visits.
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Volunteers
Inclusion criteria
o Informed consent
Exclusion criteria
o History of sensitivity and/or allergy to any of the ingredients in the study medication.
Open lesions of any kind on the hands
Concomitant cutaneous malignancy in treatment area
Immune deficiency
Participation in another clinical trial during the last 6 months
Had been previously treated with Tirbanibulin
Anticipated need for in-patient hospitalisation or in-patient surgery from Day 1 to Day 57.
Treatment with 5-fluorouracil (5-FU), imiquimod, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment area within 8 weeks prior to the Screening Visit.
Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit:
Use of the following therapies and/or medications within 4 weeks prior to the Screening Visit:
Use of systemic retinoids (e.g., isotretinoin, acitretin, bexaro-tene) within 6 months prior to the Screening Visit.
Skin disease (e.g., atopic dermatitis, psoriasis, eczema) or con-dition (e.g., scarring, open wounds) that, in the opinion of the investigator, might interfere with the study conduct or evalu-ations, or which exposed the subject to unacceptable risk by study participation.
Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would have exposed the subject to unacceptable risk by study participa-tion.
Pregnancy or lactation
Excessive exposure to UV radiation during study period.
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
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Central trial contact
Wolfgang Weger
Data sourced from clinicaltrials.gov
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