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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether topical timolol, a type of beta-blocker, can accelerate the healing of surgical wounds. It targets wounds from Mohs Micrographic Surgery, a common skin cancer procedure, that are left to heal naturally. Researchers will compare timolol to the standard care of Vaseline and a bandage to determine which is more effective. This trial may suit individuals undergoing Mohs surgery with an open wound between 0.5 cm and 4 cm, who are not on certain medications or have specific heart or lung conditions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this treatment.

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.

Is there any evidence suggesting that topical timolol is likely to be safe for humans?

Research has shown that topical timolol, a medication that blocks certain skin receptors, may accelerate wound healing. While promising, few studies have specifically examined its safety on wounds.

Timolol has long been used in eye drops for conditions like glaucoma, suggesting it might be safe. However, more research is needed to confirm its safety when applied to wounds. So far, studies on its use for wound healing have not reported major safety concerns.

This study is in an early phase and aims to determine the safety of topical timolol and how the body processes it. This careful step ensures the treatment is safe for people before testing its effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for wound healing?

Unlike the standard wound care options, which typically involve applying Vaseline and a Band-Aid, topical Timolol offers a unique approach by using a beta-blocker to aid in wound healing. Researchers are excited because Timolol, commonly used for treating glaucoma, has shown potential in enhancing wound repair by improving blood flow and reducing inflammation. This new method of applying Timolol directly to the wound may accelerate healing in a way that typical protective measures do not, offering a promising new avenue for faster recovery.

What evidence suggests that topical timolol might be an effective treatment for wound healing?

Studies have shown that topical timolol holds promise for wound healing. It blocks certain receptors, reducing swelling and supporting the healing process. Research indicates that timolol can accelerate healing for persistent wounds, such as those from diabetes or poor blood flow. In some studies, wounds treated with timolol healed faster than untreated ones. In this trial, participants will join one of two groups: one will apply topical timolol, while the other will follow standard care with Vaseline and a Band-Aid. These findings suggest that timolol might also aid in healing surgical wounds, such as those from Mohs surgery, which are left open to heal naturally. ^{1 2 3 6 7}

Who Is on the Research Team?

Jesse Lewin, MD

Principal Investigator

Primary Investigator

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06941467

NCT06941467 | Topical 0.5% Timolol Solution for Healing ... Topical timolol, a β2-Adrenergic receptor (B2AR) antagonist, has demonstrated promise in wound healing over the past several years.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6798797/

Absorption and Safety of Topically Applied Timolol for ... Application of timolol 0.5% gel-forming solution to the wound bed is being increasingly done as an off-label treatment to improve the healing of chronic wounds; ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-01062

Topical Timolol Solution for Improving Wound Healing ... Using topical timolol solution may be safe and effective in improving wound healing time after Mohs surgery in patients with cutaneous melanoma.

4. link.springer.com link.springer.com/article/10.1007/s13671-024-00421-3

The Use of Timolol for Wound Healing—A Review Its benefits are attributed to various mechanisms including improved re-epithelialization, modulation of inflammation, and wound maturation, in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X17302846

Topical timolol promotes healing of chronic leg ulcer Take Home Message: Venous and diabetic leg ulcer healing rates were significantly better at 4, 8, and 12 weeks in the 30 patients who received topical timolol ...

6. jaad.org jaad.org/article/S0190-9622(22)00275-4/fulltext

Topical timolol enhances surgical wound healing in the ... Topical timolol enhances surgical wound healing in the lower portion of the leg in older patients with comorbidities: A retrospective review

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dth.14847

The role of topical timolol in wound healing and ... The present comprehensive review study surveys the role of topical timolol in acute and chronic wound healing in the field of dermatology.