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NCT05279131 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis
A Phase 3 study, sponsored by Almirall, S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
NCT05279131: Completed Phase 3 study, sponsored by Almirall, S.A..
NCT05279131 is a Phase 3 study that has completed, run by Almirall, S.A.. The registered enrollment target is 105 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05279131, a Phase 3 study, has completed, sponsored by Almirall, S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
Study 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.
Primary Outcome
Local tolerability score was evaluated by investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point grade scale of 0 - 3, where a score of 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). The higher score indicates severe sym
Interventions
- DRUG Tirbanibulin ointment 1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2022-12-28 |
| Phase | Phase 3 |
What the finished NCT05279131 record still lists
NCT05279131 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Tirbanibulin ointment 1% is the first listed.
NCT05279131 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05279131 about?
NCT05279131 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis". 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.
What is the current status of trial NCT05279131?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2022-06-28. Estimated completion is 2022-12-28.
What interventions are being tested in trial NCT05279131?
The interventions under investigation include: Tirbanibulin ointment 1% (DRUG).
Who is sponsoring clinical trial NCT05279131?
This trial is sponsored by Almirall, S.A., which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05279131's enrollment target sits among peer trials
105 1670th of 2000 higher than 330 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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