A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With A… (NCT06135415) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis
Germany280 participantsStarted 2023-12-21
Plain-language summary
The purpose of the study is to evaluate the efficacy and safety of tirbanibulin 10 milligrams per gram (mg/g) ointment when applied to a treatment field (TF) larger than 25 centimeter square (cm\^2) and up to 100 cm\^2 in adult participants with actinic keratosis (AK).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants having a TF on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that contains \>= 4 to less than or equal to (\<=) 12 clinically typical, visible, and discrete (non-confluent) AK lesions and measures more than 25 cm2 (example, one cheek) and up to approximately 100 cm2 (example, mid face).
* Participants willing to avoid excessive sunlight or UV light exposure, including the use of tanning beds, to the face or scalp during the study.
* Women of childbearing potential (WOCBP), that is, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months prior to screening) must have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration, be using highly effective methods of birth control for at least 30 days or 1 menstrual cycle, whichever is longer, and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product, agree to have pregnancy tests while in the study and at the end of the study, and agree not to be egg (oocyte) donors while on study and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product.
* Sexually active males with…
What they're measuring
1
Percent Change From Baseline in Lesion Count at Day 57