CLINICAL TRIALS PROFILE FOR TIRBANIBULIN
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All Clinical Trials for tirbanibulin
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT05279131 ↗ | A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis | Not yet recruiting | Almirall, S.A. | Phase 3 | 2022-05-01 | 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. |
| NCT05387525 ↗ | A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp | Not yet recruiting | Almirall, S.A. | Phase 4 | 2022-08-01 | The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period. |
| NCT05713760 ↗ | Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults | Not yet recruiting | Austin Institute for Clinical Research | Phase 2 | 2023-02-15 | This is a Phase 2, Single-Arm, Open-Label, Single Center, Proof of Concept Study to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) on the neck, trunk, or extremities (excluding, axilla, anogenital, and face/scalp). |
| NCT05741294 ↗ | A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses | Recruiting | Almirall, S.A. | Phase 4 | 2023-01-17 | The purpose of the study is to assess treatment satisfaction on Day 57 in participants with Actinic Keratoses (AK) of the face or scalp following treatment with tirbanibulin ointment 1 percent (%) administered once daily for 5 consecutive days. |
| NCT05900258 ↗ | Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face | Recruiting | Medical University of Graz | Phase 4 | 2023-05-11 | Interventional, monocentric, national, single-arm, uncontrolled, open, prospective phase IV study. Since this study is not powered for confirmative testing, analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC. Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA®. Safety and efficacy are assessed at end of treatment visit (EoT, approximately 3 days after the last dose, i.e, day 8 ± 2) and at a follow-up visit (FuV) 57 ± 7 d after the start of the treatment. UV images (Canfield VISIA®) will be taken at baseline, EoT and FuV, accompanied by conventional dermatological assessment according to clinical routine. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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