This phase I trial tests the safety and effectiveness of topical timolol solution in improving wound healing time after Mohs surgery in patients with cutaneous melanoma (skin cancer). Nonmelanoma skin cancer (NMSC) represent the majority of cutaneous cancers and affects one in five Americans during their lifetime. Mohs micrographic surgery (MMS) is a special surgical technique that allows doctors to remove all the skin and underlying tissue that have cancer in a precise manner. Sometimes, the surgeons must remove a large amount of skin and tissue in order to cure the patient. When this happens, the wound might be too big for the surgeon to stich it closed during surgery and so it is left to heal on its own. The most common areas of the body that cannot be stitched are the legs. Topical beta blockers are increasingly used to treat acute and chronic open wounds. Topical timolol is not approved for the treatment of wound healing; however, evidence suggests that it may decrease healing time. Using topical timolol solution may be safe and effective in improving wound healing time after Mohs surgery in patients with cutaneous melanoma.
Additional locations may be listed on ClinicalTrials.gov for NCT06941467.
Locations matching your search criteria
United States
New York
New York
Icahn School of Medicine at Mount SinaiStatus: Active
Contact: Jesse Miller Lewin
Phone: 212-731-3316
PRIMARY OBJECTIVE:
I. To assess the efficacy of topical 0.5% timolol maleate solution in promoting wound healing of open surgical wounds < 4 cm in diameter following MMS when compared to the standard of care (SOC).
SECONDARY OBJECTIVES:
I. Evaluating the adherence to treatment at each time point.
II. Evaluating the difference in surgical wound size for wounds treated with topical 0.5% timolol maleate solution versus the SOC at each time point.
III. Evaluating the difference in cosmetic outcomes of surgical wounds treated with 0.5% topical timolol maleate solution versus the SOC at 12 weeks follow up via a modified validated scar assessment tool.
IV. Evaluating longitudinal trends using patient pain and interference with daily activities during the healing process in patients with open wounds treated with topical 0.5% timolol versus the SOC via a validated pain-related functioning assessment tool.
V. Evaluating longitudinal trends using the wound care (WCQOL) in patients with open wounds treated with topical 0.5% timolol versus the SOC via a validated assessment tool to assess quality of life (QOL).
VI. Evaluating the occurrence and duration of adverse events.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Beginning the day after surgery, patients apply 1-3 drops of timolol solution topically to skin daily (QD) for 12 weeks.
GROUP II: Beginning the day after surgery, patients apply SOC petroleum jelly topically to skin QD for 12 weeks.
After completion of study intervention, patients are followed up at 2 - 4, 8, and 12 weeks post-surgery 12 weeks after surgery.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorJesse Miller Lewin
