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Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands

Primary Purpose

Actinic Keratoses

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tirbanibulin
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tirbanibulin

    Placebo

    Arm Description

    Treatment

    Placebo

    Outcomes

    Primary Outcome Measures

    Partial clearance at day 57 ± 7 after start of blinded treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    August 30, 2023
    Last Updated
    September 6, 2023
    Sponsor
    Medical University of Graz
    Collaborators
    Almirall, SAS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06026358
    Brief Title
    Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands
    Official Title
    Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands. An Internally Placebo Controlled, Partly Blinded Clinical Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Graz
    Collaborators
    Almirall, SAS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Actinic Keratoses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tirbanibulin
    Arm Type
    Experimental
    Arm Description
    Treatment
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Tirbanibulin
    Intervention Description
    subjects receive 2,5 mgTirbanibulin in 250 mg ointment with daily administration of one single sachet on the left hand and 250mg ointment placebo on the right hand for 5 d in a single-blinded manner.
    Primary Outcome Measure Information:
    Title
    Partial clearance at day 57 ± 7 after start of blinded treatment
    Time Frame
    day 57 ± 7 after start of blinded treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wolfgang Weger
    Phone
    +43385
    Ext
    2371
    Email
    wolfgang.weger@medunigraz.at

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands

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