Topical Timolol: a Comparison of Surgical Outcomes

Wound Heal Clinical Trial

Official title:

Topical Timolol: a Comparison of Surgical Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114239
• Other study ID #: 1227
• Status: Recruiting
• Phase: Phase 2
• Start date: April 7, 2021
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: Taylor G Dickerson, MD
• Phone: (504) 568-7110
• Email: tgrif3[@]lsuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal

Intervention

Drug:
• Timolol 0.25% Ophthalmic Solution
Applied to treatment side prior to standard wound care

Other:
• Standard Wound Care
Wound is washed twice a day with soap and then petrolatum and a bandage is applied.

Locations

Country	Name	City	State
United States	Skin Surgery Centre	Metairie	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Keith G. LeBlanc, Jr, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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