Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults (NCT05713760) | Clinical Trial Compass
CompletedPhase 2
Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults
United States5 participantsStarted 2023-04-17
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females ≥ 18 years old.
✓. Willingness and ability to sign the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent form and a HIPAA form must be obtained in writing for all subjects prior to starting any study procedures.
✓. Present of 1 naïve sBCC on the neck, trunk, or extremities (excluding, axilla, anogenital, and face/scalp) that:
✓. sBCC assessed as non-naïve (e.g., previously treated, or recurrent) or non-eligible by biopsy and at least 5cm away from an eligible lesion should be excised or treated with Electrodesiccation and Curettage (ED\&C) in a timely manner.
✓. Free of significant physical abnormalities (e.g., tattoos, dermatoses) within the potential treatment area plus a 5cm radius surrounding the lesion as they may interfere with examination or final evaluation, in the opinion of the investigator.
✓. Willingness to stop the use of moisturizers, sunscreens, and any other cosmetics within the treatment area plus a 5cm radius from screening until final the visit.
✓. Willingness to abstain from sunbathing or the use of artificial tanning from screening until the final visit. Subjects with a sunburn in the treatment area cannot be included until fully recovered.
✓. Subjects must be healthy or have a medical condition that is stable in the opinion of the investigator.
Exclusion criteria
✕. Location of the treatment area is:
What they're measuring
1
Complete clearance rate of sBCC lesion
Timeframe: 26 days for subjects who completed 1 course of treatment and 51 days for subjects who completed 2 courses of treatment
. Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57.
✕. Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for Actinic Keratosis (AK) within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening visit.
✕. Use of the following therapies and/or medications within 2 weeks prior to the Screening visit:
✕. Use of the following therapies and/or medications within 4 weeks prior to the Screening visit:
✕. A history of sensitivity and/or allergy to any of the ingredients in the study medication.
✕. A skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the subject to unacceptable risk by study participation.
✕. Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the subject to unacceptable risk by study participation.