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

NCT06026358 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-05-30

No results posted yet for this study

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

Interventions

DRUG

Tirbanibulin

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.

Sponsors & Collaborators

  • Almirall, SAS

    collaborator INDUSTRY

  • Medical University of Graz

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2024-12-31
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06026358 on ClinicalTrials.gov