CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 105 enrolled
Drug / intervention
Tirbanibulin ointment 1%drug
Likely dose
Tirbanibulin ointment 1% applied topically for 5 daysAI-extracted
Key inclusion· 3
  • ✓Treatment field on face or balding scalp (excluding lips, eyelids, inside nostrils/ears) measuring approximately 100 cm² containing 4 to 12 clinically typical, visible, and discrete actinic keratosis lesions
  • ✓Willing to avoid excessive sunlight or UV light exposure including tanning beds to face or scalp during study
  • ✓Ability to understand study purpose and risks, willingness to comply with protocol, and written informed consent provided
Key exclusion· 9
  • ✕Clinically atypical and/or rapidly changing AK lesions in the treatment field
  • ✕Hyperkeratotic or hypertrophic lesions, recalcitrant disease (cryosurgery on 2 prior occasions), and/or cutaneous horn in treatment field
  • ✕Confluent (non-discrete) AK lesions in treatment field
  • ✕History of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumors in treatment field

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05279131
NCT05279131Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% Applied to a Field of Approximately 100 cm2 on the Face or Balding Scalp in Adult Patients With Actinic Keratosis

Almirall, S.A.·interventional·Posted Mar 15, 2022·Updated Jan 23, 2024

In Brief

A Phase 3 clinical trial evaluating Tirbanibulin ointment 1% for Keratosis, Actinic. Completed, enrolled 105 participants across 7 sites.

Detailed Summary

The purpose of the study is to evaluate the safety, tolerability and treatment effect of tirbanibulin ointment 1% when applied to a field of approximately 100 cm\^2 on the face or balding scalp.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratosis, Actinic
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMar 15, 2022
Enrollment StartJun 28, 2022
Primary CompletionDec 28, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.3 years ago

Interventions

Tirbanibulin ointment 1%drug

Applied topically for 5 days over a field of approximately 100 cm\^2 on the face or balding scalp with AK.