Topical Timolol for Wound Healing

Overseen By Jaclyn Himeles, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Beta-blockers, Clonidine, Digoxin, others

Disqualifiers: Pregnancy, Heart failure, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

102 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking oral beta-blockers or certain other medications like clonidine, digoxin, or fluoxetine, you cannot participate in this trial. The protocol does not specify a washout period, but you would need to stop these medications to join.

What data supports the effectiveness of the drug Timolol for wound healing?

Research shows that topical Timolol has been effective in healing chronic wounds, with 34 out of 55 wounds completely healing and 15 improving in size. Additionally, Timolol has been shown to promote skin cell movement and blood vessel formation, which are important for wound healing. ^{1 2 3 4 5}

Is topical timolol safe for use in humans?

Topical timolol has been used safely for various skin conditions, but it is important to monitor for potential side effects, especially in people with heart or lung issues. Studies show that its safety profile is similar to its use in eye treatments, with no significant adverse effects observed in wound healing applications. ^{1 5 6 7 8}

How does the drug timolol differ from other treatments for wound healing?

Timolol is unique for wound healing because it is applied topically (directly on the skin) and works by promoting re-epithelialization (skin cell growth) and reducing blood flow to the area, which helps in healing chronic wounds. Unlike other treatments, it is a nonselective β-adrenergic receptor blocker, commonly used for eye conditions, but now showing promise for various skin conditions. ^{1 2 4 5 6}

What is the purpose of this trial?

Topical timolol, a β2-Adrenergic receptor (B2AR) antagonist, has demonstrated promise in wound healing over the past several years. The majority of the literature has evaluated the use of topical timolol to shorten wound healing time in chronic wounds of non-surgical etiologies. To date, there are no prospective randomized clinical trials evaluating the role of topical timolol for shortening wound healing time in acute open surgical wounds. Therefore, the purpose of this study is to determine whether or not topical timolol solution decreases time to wound healing in patients with defects after Mohs Micrographic Surgery (MMS) that cannot be closed with sutures and are left to heal by second intent. The research team also will look to determine if there is a difference in cosmesis of wounds treated with topical timolol compared to those treated with the standard of care. The present study will primarily focus on wounds in the distal lower extremity as these are most commonly left to heal by secondary intent

Research Team

Jesse Lewin, MD

Principal Investigator

Primary Investigator

Eligibility Criteria

This trial is for individuals with open surgical wounds from unintentional home injuries or Mohs Surgery, specifically on the lower extremity that are healing by secondary intent. Details about who can join or reasons for exclusion aren't provided.

Inclusion Criteria

I have a surgical wound between 0.5 cm and 4 cm.

English-speaking

Provide a signed and dated informed consent form

Exclusion Criteria

Pregnant women

My tumor cannot be completely removed with surgery.

Breastfeeding women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply 1-3 drops of topical 0.5% timolol solution daily to the wound or follow the standard of care with Vaseline and Band-Aid

12 weeks

Regular follow-ups at 2, 4, 6, and 12 weeks

Follow-up

Participants are monitored for wound healing, cosmesis, and quality of life after treatment

4 weeks

Treatment Details

Interventions

• Timolol

Trial Overview The study tests if a topical solution called Timolol Maleate can speed up wound healing compared to standard care. It's a randomized trial focusing on acute wounds after surgery that cannot be closed with stitches.

Participant Groups

Group I: Timolol Experimental Treatment 1 Intervention

Participants in the topical timolol group will be instructed to apply 1-3 drops of topical 0.5% timolol solution daily to the wound.

Group II: Standard of Care Active Control 1 Intervention

Standard of Care - Apply Vaseline and Band-Aid to wound bed daily

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of Topical Timolol Maleate as Re-Epithelialization Agent for Treatment of Recalcitrant Wounds of Varying Etiologies. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Topical timolol promotes healing of chronic leg ulcer. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Beta-adrenergic antagonist for the healing of chronic diabetic foot ulcers: study protocol for a prospective, randomized, double-blinded, controlled and parallel-group study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Topical timolol in dermatology: infantile haemangiomas and beyond. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Absorption and Safety of Topically Applied Timolol for Treatment of Chronic Cutaneous Wounds. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Topical timolol 0.5% as the primary treatment of ophthalmic pyogenic granuloma: A prospective, single-arm study. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Repurposing Ophthalmologic Timolol for Dermatologic Use: Caveats and Historical Review of Adverse Events. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Potential side effects of timolol therapy in the treatment of glaucoma. [2013]