Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT06026358
Eligibility Criteria:
Inclusion Criteria:
* o Informed consent
* Diagnosed with AK on both hands
* 4-8 AK lesions on each hand, difference in number of lesions \< 20%
* Grade of lesions comparable in both hands: non hypertrophic, non-hyperkeratotic
* Willing and able to comply with all study procedures
* Use of medically acceptable contraception (both sexes)
* 18 - 99 years of age.
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:
* Cosmetic or therapeutic procedures (eg, use of liquid nitro-gen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treat-ment area
* Acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha and beta-hydroxyl acids and gly-colic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treat-ment area
* Topical salves (nonmedicated/nonirritant lotion and cream were acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artifi-cial tanners within the treatment area or within 5 cm of the selected treatment area.
* Use of the following therapies and/or medications within 4 weeks prior to the Screening Visit:
* Treatment with immunomodulators (eg, azathioprine), cy-totoxic drugs (e.g., cyclophosphamide, vinblastine, chlo-rambucil, methotrexate) or interferons/interferon induc-ers.
* Treatment with systemic medications that suppress the im-mune system (e.g., cyclosporine, prednisone, methotrex-ate, alefacept, infliximab).
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06026358
Study Brief:
Protocol Section:
NCT06026358