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

NCT06026358 | Withdrawn Phase 4

• 1 other identifier: Tirbanibulin: Back of Hands
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

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

  day 57 ± 7 after start of blinded treatment

Study Arms (2)

Tirbanibulin

EXPERIMENTAL

Treatment

Drug: Tirbanibulin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Tirbanibulin

Interventions

Tirbanibulin DRUG

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.

Placebo; Tirbanibulin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• o Informed consent
• Diagnosed with AK on both hands
• 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)
• years of age.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Graz: lead
• Almirall, SAS: collaborator

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

tirbanibulin

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share