Topical Timolol: a Comparison of Surgical Outcomes

NCT ID: NCT05114239

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-07

Study Completion Date

2022-12-31

Brief Summary

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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

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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;

Conditions

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Wound Heal

Keywords

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Timolol Wound healing Surgical Wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Timolol

Timolol 0.25% applied to distal or posterior half of wound edge twice daily prior and adjunct to prior wound care.

Group Type EXPERIMENTAL

Timolol 0.25% Ophthalmic Solution

Intervention Type DRUG

Applied to treatment side prior to standard wound care

Standard Wound Care

Petrolatum ointment

Group Type PLACEBO_COMPARATOR

Standard Wound Care

Intervention Type OTHER

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

Interventions

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Timolol 0.25% Ophthalmic Solution

Applied to treatment side prior to standard wound care

Intervention Type DRUG

Standard Wound Care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Keith G. LeBlanc, Jr, MD

OTHER

Sponsor Role lead

Responsible Party

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Keith G. LeBlanc, Jr, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Keith G LeBlanc, MD

Role: PRINCIPAL_INVESTIGATOR

LSU HSC New Orleans

Locations

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Skin Surgery Centre

Metairie, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Taylor G Dickerson, MD

Role: CONTACT

Phone: (504) 568-7110

Email: [email protected]

Keith LeBlanc, MD

Role: CONTACT

Phone: (504) 644-4226

Email: [email protected]

Facility Contacts

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Taylor G Dickerson, MD

Role: primary

Keith Leblanc, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 38261740 (View on PubMed)

Other Identifiers

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1227

Identifier Type: -

Identifier Source: org_study_id