A Phase 2/3 interventional study of 0.25% Timolol gel with paraffin gauze dressings and Vaseline dressing in Wound of Skin, Wound Heal and Wound Open, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Brigham and Women's Hospital · Phase 2/3, Interventional, and Treatment
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Among 129 studies in Surgical Wound with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Surgical Wound · United States.
Among the 129 studies in Surgical Wound with a site in United States, this one is the 38th largest by enrollment of the 111 interventional ones that give a count, is one of 12 that started in 2018, is one of 2 in phase 2/3, and was the 53rd registered.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
Browse Surgical Wound studies →17 of the 129 studies in Surgical Wound with a site in United States are open now. Recruiting first, the newest first:
The Metis Foundation · Sites in United States
Ages 18–85
Acera Surgical, Inc. · Sites in United States
Ages 18+
University of Nevada, Las Vegas · Sites in United States
Ages 18+ · Healthy volunteers
Hospital for Special Surgery, New York · Sites in United States
Ages 18+
Venus Concept · Sites in United States
Ages 21–75 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 33 Surgical Wound studies recruiting now, 19 (58%) set no upper age limit and 10 (30%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
129 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 4 · Phase 4 11
First in 2004; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 87 is above the median of 66 across 242 interventional studies indexed under Surgical Wound.
Median enrollment 50 across the 111 interventional studies, 46 across the 18 observational. Of the 87 that completed or were terminated, 43 (49%) have results posted.
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45 of 129 have an industry lead sponsor. The 10 most frequent:
Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Brigham and Women's Hospital has 2 studies filed under Surgical Wound — fewer than ten, so there is no comparison to draw.
9 of the studies in Surgical Wound with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06259409Progenerative Medical, IncRegenn® Therapy System Safety Study | 2026-12 |
| NCT04718168W.L.Gore & AssociatesGORE® ENFORM Biomaterial Product Study | 2026-12 |
| NCT06014411Hospital for Special Surgery, New YorkEarly Versus Delayed Bathing of Orthopaedic Surgical Wounds | 2026-12 |
| NCT07653165West Boca Center for Wound HealingUse of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds | 2026-12-31 |
| NCT04786106Charitable Union for the Research and Education of Peyronie's DiseaseInvestigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's | 2027-02-15 |
Add all 9 to your calendar (.ics) → With an account.
Among the 129 studies in Surgical Wound with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The use of topical beta-blockers, such as 0.25% timolol, in promoting wound healing is currently emerging in the academic literature. The investigators will enroll 114 patients who have their skin cancer surgically removed resulting in open surgical wounds less or equal to 1.5 cm. The objective of this randomized safety study is to determine the safety and efficacy of 0.25% timolol in promoting wound healing in open surgical wounds less or equal to 1.5 cm.
Healing of a cutaneous defect by second intention is a complex process. Migration of fibroblasts, keratinocytes, and other cell types to the site of defect and their proliferation under stimulation by cytokines and growth factors occur during this process. The role of topical beta-blockers in promoting wound healing is currently emerging in the international literature (1-3). β2-Adrenergic receptors (B2AR) are the only subtype of beta-adrenoceptors expressed on skin (4-6). They can be found in secretory coil of apocrine glands, keratinocytes, fibroblasts and melanocytes. The distribution of these receptors provides insight on dermatological disorders that may be affected by β-blockers. Keratinocyte migration occurs by the facilitation of chemotaxis, the polarization of cells, and activation of extracellular signal-related kinases essential in the signaling of promigratory pathways. The B2AR activation inhibits keratinocyte migration by activating the serine/threonine phosphatase 2A, which downregulates phosphorylation of extracellular signal-related kinases necessary for migration. Therefore, B2AR antagonists prevent the phosphorylation of phosphatase 2A and have the downstream effect of extracellular signal-related kinase promotion, inducing a promigratory pathway in keratinocytes (4-6). Keratinocyte migration also occurs by galvanotaxis, a phenomenon in which cells migrate in response to electric stimuli. Keratinocytes can be stimulated to migrate with the formation of electrical poles and the application of electrical fields. The B2AR antagonists improve the ability of keratinocytes to respond to such migratory cues, whereas the B2AR agonists decrease keratinocytes' ability to respond, further implicating the use of topical timolol for recalcitrant wounds (4-6). Angiogenesis and dermal fibroblast proliferation are also regulated by B2ARs. The B2AR antagonists have been found to promote angiogenesis in chick chorioallantoic membrane assays and in vivo murine wound models. Dermal fibroblast migration is also increased (by 27%) when exposed to B2AR antagonists, and epidermal differentiation is improved with B2AR antagonists and β1- and β2-receptor antagonists (5-10).
Topical beta-blockers have been gaining increasing popularity and evidence over the last few years as enhancers of wound healing in acute and chronic open wounds. In particular, 0.25% timolol gel may represent a commercially available, safe and simple, painless-though perhaps moderately expensive-treatment for improving both acute and chronic open wounds, as well as for improving long-term cosmetic outcomes.
To assess the efficacy and safety of topically applied 0.25% timolol gel in promoting wound healing in surgical open wounds ≤1.5cm versus standard of care (SOC) by:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied 2. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply 0.25% topical timolol gel (1 drop = 0.1ml for each cm2 of wound area), and re-cover wound with clean dressing 3. This daily routine continues for 12 weeks' post-surgery (even if the surgical defect has completely healed in the interim)
Drug: 0.25% Timolol gel with paraffin gauze dressings
1. Vaseline will be applied to wound bed immediately after surgery before dressing is applied 2. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply Vaseline, and re-cover wound with clean dressing 3. This daily routine continues for 12 weeks' post-surgery (even if the surgical defect has completely healed in the interim)
Other: Vaseline dressing
Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply 0.25% topical timolol gel (1 drop = 0.1ml for each cm2 of wound area), and re-cover wound with clean dressing
Vaseline will be applied to wound bed immediately after surgery before dressing is applied. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply Vaseline, and re-cover wound with clean dressing
Number of Participants With Re-epithelialization at 30 Days Post op
Evaluating the difference in wound re-epithelialization at 30 days after surgery between the groups. Re-epithelialization (yes vs. no) will be evaluated by 2 independent investigators.
Time frame: 30 days' post-surgery
Cosmetic Outcomes of Open Surgical Wound Healing by Blinded Physician Vancouver Scar Scale Assessment
A physician blinded to the treatment group the subject is in will self-administer the Vancouver Scar Scale (VSS) which documents change in scar appearance over time via standardized photographs. The VSS ranges from 0 (most desirable outcome) to 13 (least desirable outcome), thus, a lower score is considered to have a better outcome and a higher score is considered a worse outcome. The VSS consists of four sub-scales, with each sub-scale reporting a value. The "pigmentation sub-scale" ranges from 0 (normal pigmentation) to 2 (hyperpigmentation); the "vascularity sub-scale" ranges from 0 (normal appearance) to 3 (purple appearance); the "pliability sub-scale" ranges from 0 (normal pliability) to 5 (contracture); and the "height sub-scale" ranges from 0 (normal \[flat\]) to 3 (\>5mm). Sub-scale scores are combined to give an overall VSS assessment score.
Time frame: 3 months' post-surgery
Study Subject Complete the Patient Scar Assessment Via Visual Analogue Scale
Subjects will be asked to complete a Visual Analogue Scale for scar assessment to rate how they think their graft sites appear cosmetically compared to normal skin. The score ranges from 1 (no complaints with how scar appears cosmetically to normal skin) to 10 (worst imaginable scar compared to normal skin). A lower score is considered to have a better outcome and a higher score is considered a worse outcome.
Time frame: 6 months' post-surgery
Number of Participants Whose Side Effects Are Associated With 0.25% Topical Timolol for Open Surgical Wounds
Patients will report and side effects they experience post-surgery. A physician will also assess for side effects and determine whether they are likely associated with the 0.25% topical timolol or part of the normal wound healing experience.
Time frame: Up to 6 months' post-surgery
| Milestone | 0.25% Timolol Gel Under the Paraffin Gauzes | Standard of Care Dressings |
|---|---|---|
| Started | 44 | 43 |
| Completed | 34 | 33 |
| Not completed | 10 | 10 |
| Withdrew: Lost to follow-up | 7 | 7 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Physician decision | 1 | 1 |
Evaluating the difference in wound re-epithelialization at 30 days after surgery between the groups. Re-epithelialization (yes vs. no) will be evaluated by 2 independent investigators.
| participants | 0.25% Timolol Gel Under the Paraffin Gauzes | Standard of Care Dressings |
|---|---|---|
| Number of Participants With Re-epithelialization at 30 Days Post op | 9 | 12 |
A physician blinded to the treatment group the subject is in will self-administer the Vancouver Scar Scale (VSS) which documents change in scar appearance over time via standardized photographs. The VSS ranges from 0 (most desirable outcome) to 13 (least desirable outcome), thus, a lower score is considered to have a better outcome and a higher score is considered a worse outcome. The VSS consists of four sub-scales, with each sub-scale reporting a value. The "pigmentation sub-scale" ranges from 0 (normal pigmentation) to 2 (hyperpigmentation); the "vascularity sub-scale" ranges from 0 (normal appearance) to 3 (purple appearance); the "pliability sub-scale" ranges from 0 (normal pliability) to 5 (contracture); and the "height sub-scale" ranges from 0 (normal \[flat\]) to 3 (\>5mm). Sub-scale scores are combined to give an overall VSS assessment score.
| score on a scale | 0.25% Timolol Gel Under the Paraffin Gauzes | Standard of Care Dressings |
|---|---|---|
| Cosmetic Outcomes of Open Surgical Wound Healing by Blinded Physician Vancouver Scar Scale Assessment | 8.8 ± 1.6 | 8.8 ± 2 |
Subjects will be asked to complete a Visual Analogue Scale for scar assessment to rate how they think their graft sites appear cosmetically compared to normal skin. The score ranges from 1 (no complaints with how scar appears cosmetically to normal skin) to 10 (worst imaginable scar compared to normal skin). A lower score is considered to have a better outcome and a higher score is considered a worse outcome.
| score on a scale | 0.25% Timolol Gel Under the Paraffin Gauzes | Standard of Care Dressings |
|---|---|---|
| Study Subject Complete the Patient Scar Assessment Via Visual Analogue Scale | 5.71 ± 4.44 | 5.97 ± 4.34 |
Patients will report and side effects they experience post-surgery. A physician will also assess for side effects and determine whether they are likely associated with the 0.25% topical timolol or part of the normal wound healing experience.
| Participants | 0.25% Timolol Gel Under the Paraffin Gauzes | Standard of Care Dressings |
|---|---|---|
| Number of Participants Whose Side Effects Are Associated With 0.25% Topical Timolol for Open Surgical Wounds | 1 | 0 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.25% Timolol Gel Under the Paraffin Gauzes | 0/44 (0%) | 0/44 (0%) | 1/44 (2.3%) |
| Standard of Care Dressings | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Event | 0.25% Timolol Gel Under the Paraffin Gauzes | Standard of Care Dressings |
|---|---|---|
| Temporary tinnitus, nausea and headacheNervous system disorders | 1/44 | 0/43 |
| Age, Continuous(years) | 0.25% Timolol Gel Under the Paraffin Gauzes | Standard of Care Dressings | Total |
|---|---|---|---|
| Mean | 70.26 ± 10.20 | 70.82 ± 8.36 | 70.44 ± 9.82 |
| Sex: Female, Male(Participants) | 0.25% Timolol Gel Under the Paraffin Gauzes | Standard of Care Dressings | Total |
|---|---|---|---|
| Female | 20 | 15 | 35 |
| Male | 24 | 28 | 52 |
| Race and Ethnicity Not Collected(Participants) | 0.25% Timolol Gel Under the Paraffin Gauzes | Standard of Care Dressings | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | 0.25% Timolol Gel Under the Paraffin Gauzes | Standard of Care Dressings | Total |
|---|---|---|---|
| United States | 44 | 43 | 87 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Aug 2018 to primary completion in Dec 2020, 28 months.
Results were first posted in May 2026, 5 years 4 months after primary completion.
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