Status:
WITHDRAWN
Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands
Lead Sponsor:
Medical University of Graz
Collaborating Sponsors:
Almirall, SAS
Conditions:
Actinic Keratoses
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
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 treatme...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06026358
Start Date
October 1 2023
End Date
December 1 2024
Last Update
May 30 2024
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