Topical Timolol: a Comparison of Surgical Outcomes

Phase 2

• Conditions: Wound Heal
• Interventions: Drug: Timolol 0.25% Ophthalmic Solution; Other: Standard Wound Care

• Registration Number: NCT05114239
• Lead Sponsor: Keith G. LeBlanc, Jr, MD

Brief Summary

The use of topical beta-blockers, such as 0.25% timolol, in promoting wound healing is currently emerging in the literature. The investigators will enroll 30 participants in a split scar study who have their skin cancer surgically removed resulting in a linear wound equal to or longer than 4cm. The objective of this randomized study is to determine the safety and efficacy of 0.25% timolol in promoting wound healing in wound closed primarily greater than or equal to 1.5 cm.

Detailed Description

Topical timolol has shown in case series to improve healing time and cosmetic outcome of ulcerated or non-healing wounds with improved cosmetic outcome when compared to standard wound care. There is currently no research detailing if this improved outcome is applicable when used with wounds approximated with sutures.

Mechanism of action is not fully elucidated but improved keratinocyte migration and suppression of the inflammatory cascade is thought to improve wound healing. Skin cancer surgeries have morbidity for patients as they are often in cosmetically sensitive locations. Improving cosmetic outcomes of surgical scars could improve patient outcomes and overall satisfaction.

The goal of this study is to determine if topical timolol will improve long-term cosmetic outcomes of surgical scars and thereby improve patient outcomes. There is great variability in how a surgical site heals depending on patient factors as well as surgical site location. The investigators will perform a split scar study to allow each patient to be their own control to account for this variability.

To assess the efficacy and safety of topically applied 0.25% timolol in promoting wound healing in surgical primary linear wound greater than or equal to 4cm versus standard of care (SOC) by:

1. Evaluating cosmetic outcomes of surgical wounds in terms of blinded physician and patient assessment at 30 days and 90days following suture removal

2. Evaluating patient discomfort by patient questionnaire.

3. Determining the side effects associated to 0.25% topical timolol versus SOC;

Study Timeline

• Study Start: 2021-04-07
• Study First Submitted: 2021-07-02
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-29
• Last Update Submitted: 2021-10-29
• Study First Posted: 2021-11-09
• Last Update Posted: 2021-11-09
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• skin wounds greater than or equal to 4cm, closed primarily and linearly following standard excision or Mohs

Exclusion Criteria

• Past medical history of psoriasis
• known history of sensitivity to beta blockers or topical timolol
• pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol	Timolol 0.25% Ophthalmic Solution	Timolol 0.25% applied to distal or posterior half of wound edge twice daily prior and adjunct to prior wound care.
Standard Wound Care	Standard Wound Care	Petrolatum ointment

Primary Outcome Measures

Name	Time	Method
Observed cosmetic difference of scar in treatment side versus control: Yes or no	3 months after suture removal	Photo review of objective cosmetic difference by blinded physician

Trial Locations

Locations (1)

Skin Surgery Centre; 🇺🇸 Metairie, Louisiana, United States