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Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead

NCT07273656 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-05-22

No results posted yet for this study

Summary

The aim of the study is to evaluate the efficacy and safety of a combined approach of cryotherapy and tirbanibulin for the treatment of actinic keratosis of the scalp and forehead, repeated every 4 months. A higher rate of complete response is expected with this combination compared to cryotherapy alone, as well as a better response with repeated treatment cycles.

Conditions

  • Keratosis
  • Actinic Keratoses

Interventions

DRUG

Cryotherapy + Tirbanibulin

Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months)

Sponsors & Collaborators

  • Almirall, SAS

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-11-30
Completion
2028-11-30

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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 NCT07273656 on ClinicalTrials.gov