Topical Timolol: a Comparison of Surgical Outcomes

NCT05114239 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 1227
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal

Keywords

Timolol; Wound healing; Surgical Wounds

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Timolol

EXPERIMENTAL

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

Standard Wound Care

PLACEBO COMPARATOR

Petrolatum ointment

Other: Standard Wound Care

Interventions

Timolol 0.25% Ophthalmic Solution DRUG

Applied to treatment side prior to standard wound care

Timolol

Standard Wound Care OTHER

Wound is washed twice a day with soap and then petrolatum and a bandage is applied.

Standard Wound Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Keith G. LeBlanc, Jr, MD: lead

Study Sites (1)

Skin Surgery Centre

Metairie, Louisiana, 70005, United States

RECRUITING

Related Publications (1)

• Jeha GM, Dickerson T, Hargrave L, Bao-Loc-Trung M, Prusisz T, Bucher E, Rougelot RC, LeBlanc K Jr. Does Timolol Solution Improve the Appearance of Acute Surgical Wounds After Mohs Surgery? A Split-Scar Clinical Study. Dermatol Surg. 2024 May 1;50(5):481-483. doi: 10.1097/DSS.0000000000004094. Epub 2024 Jan 23. No abstract available.

  PMID: 38261740 DERIVED

MeSH Terms

Conditions

Surgical Wound

Interventions

Timolol; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Keith G LeBlanc, MD

  LSU HSC New Orleans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor G Dickerson, MD

CONTACT

(504) 568-7110; tgrif3@lsuhsc.edu

Keith LeBlanc, MD

CONTACT

(504) 644-4226; klebl2@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: November 9, 2021
• Study Start: April 7, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 9, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)