Topical Timolol: a Comparison of Surgical Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Heal
• Intervention / Treatment: Drug: Timolol 0.25% Ophthalmic Solution; Other: Standard Wound Care

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Taylor G Dickerson, MD; Phone Number: (504) 568-7110; Email: tgrif3@lsuhsc.edu
• Study Contact Backup: Name: Keith LeBlanc, MD; Phone Number: (504) 644-4226; Email: klebl2@gmail.com

Study Locations

• United States
  • Louisiana
    • Metairie, Louisiana, United States, 70005
      • Recruiting
      • Skin Surgery Centre
      • Contact: Taylor G Dickerson, MD; Phone Number: 225-955-3679; Email: tgrif3@lsuhsc.edu
      • Contact: Keith Leblanc, MD; Phone Number: 504-644-4226; Email: kleb12@lsuhsc.edu
      • Principal Investigator: Keith Leblanc, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Timolol; Timolol 0.25% applied to distal or posterior half of wound edge twice daily prior and adjunct to prior wound care.	Drug: Timolol 0.25% Ophthalmic Solution; Applied to treatment side prior to standard wound care
Placebo Comparator: Standard Wound Care; Petrolatum ointment	Other: Standard Wound Care; Wound is washed twice a day with soap and then petrolatum and a bandage is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed cosmetic difference of scar in treatment side versus control: Yes or no	Photo review of objective cosmetic difference by blinded physician	1 month after suture removal
Observed cosmetic difference of scar in treatment side versus control: Yes or no	Photo review of objective cosmetic difference by blinded physician	3 months after suture removal

Collaborators and Investigators

• Sponsor: Keith G. LeBlanc, Jr, MD
• Investigators: Principal Investigator: Keith G LeBlanc, MD, LSU HSC New Orleans

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Wound healing; Timolol; Surgical Wounds
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Timolol; Ophthalmic Solutions
• Other Study ID Numbers: 1227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes