Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Almirall, S.A.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Having a treatment field (TF) on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that measures approximately 100 cm\^2 (eg, mid face) and contains 4 to 12 clinically typical, visible, and discrete actinic keratosis (AK) lesions within the TF
Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study
Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provided written informed consent in accordance with institutional and regulatory guidelines
4. History of invasive squamous cell carcinoma (SCC), Bowen's disease, basal cell carcinoma (BCC), or other malignant tumors in the TF
5. Any other dermatological disease that causes difficulty with examination
Previous treatment with tirbanibulin ointment 1%.
Anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day 57
Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the TF or within 2 cm of the TF, within 8 weeks prior to the Screening visit
Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit
You may not be if
Presence in the TF of
1. Clinically atypical and/or rapidly changing AK lesions in the TF
2. Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions) and/or cutaneous horn
Clareo Health | A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis
