Wound of SkinPhase 2/3FTSGNCT03579160

Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes

A Phase 2/3 study testing 0.25% timolol gel with full-thickness skin grafts and Vaseline dressing in people with Wound of Skin and Wound Heal, run by Brigham and Women's Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Wound of Skin, Wound Heal, Surgical Wound
What is being tested?: 0.25% timolol gel with full-thickness skin grafts and Vaseline dressing
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 2 Jan 2019to 10 Jan 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age ≥18 years of age
Undergoing a procedure which results in the need of a FTSG
Willing to provide written informed consent

Who cannot join

Age less than 18 years of age
Pregnant women
(Use of systemic drugs that can impede wound healing, such retinoids or immune-suppressive drugs)
Severe coagulation disorders
Severe, uncontrolled systemic comorbidities, such as diabetes, arthritis, etc.
Hypersensitivity to 0.25% timolol gel
Not willing to provide written informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Mohs and Dermatologic Surgery Center, Brigham and Women's Hospital
Boston, Massachusetts, 02130

Other trials in United States

About this study

Official title: Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes: A Randomized, Controlled Trial

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 82 patients who have their skin cancer surgically removed resulting in the need of a full-thickness skin graft. The objective of this randomized safety study is to determine the safety and efficacy of 0.25% timolol in promoting wound healing in full-thickness skin grafts compared to standard of care.

Read the detailed description

The role of topical beta-blockers in promoting wound healing is currently emerging in the international literature. β2-Adrenergic receptors (B2AR) are the only subtype of beta-adrenoceptors expressed on skin. 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. 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. 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.

Full-thickness skin grafts (FTSG) are one of the most commonly performed procedures in dermatologic, plastic and burn surgery. Various experimental approaches to optimize the healing of FTSG receiving sites have been described; however, no clearly superior and easily applicable method has gained wide acceptance in daily practice.

As indicated by preliminary evidence in other wound healing endeavors, 0.25% timolol gel may represent a commercially available, safe and simple, painless and relatively inexpensive treatment for improving healing of FTSG receiving site, as well as for improving cosmetic long term outcomes.

To assess the efficacy and safety of topically applied 0.25% timolol gel in promoting wound healing in FTSG receiving site versus standard of care (SOC) by:

Evaluating healing in response to treatment with 0.25% topical timolol gel versus SOC in terms of wound surface area and Graft Take Score at the receiving site of a FTSG at 7 and 14 days;
Evaluating cosmetic outcomes of the receiving site of a FTSG in terms of blinded physician (Vancouver Scar Scale, VSS) and patient (Visual Analogue Scale, VAS) assessment at 3 and 6 months' follow up;
Evaluating the need for further scar revision (dermabrasion or pulsed dye laser [PDL]) at the 6-month follow up;
Evaluating patient discomfort during the healing process by means of a patient pain VAS; and
Determining the side effects associated with 0.25% timolol gel versus SOC

Conditions: Wound of Skin, Wound Heal, Surgical Wound, Full Thickness Skin Graft Healing
Being tested: 0.25% timolol gel with full-thickness skin grafts, Vaseline dressing
Medical subject headings: Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.25% timolol gel with full-thickness skin graftsDrug
Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.
Vaseline dressingOther
Vaseline will be applied to wound bed immediately after surgery before dressing is applied.

Study groups in NCT03579160
Study group	Role	What they receive
0.25% Timolol gel applied to full-thickness skin graft	Experimental	1. During surgery: application of 0.25% timolol gel (2 drops per cm2) on wound bed before FTSG is placed 2. During surgery: application of 0.25% timolol gel (2 drops per cm2) over FTSG after insetting of the graft 3. After bolster removal (7 days): daily cleansing and daily 0.25% timolol (2 drops per cm2) application for 4 weeks Receives: Drug: 0.25% timolol gel with full-thickness skin grafts
Standard of Care dressings	Active comparator	1. FTSG surgery as per SOC 2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks Receives: Other: Vaseline dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

Healed Wound Surface in Response to Treatment With 0.25% Topical Timolol Gel Versus SOC in Terms of Wound Surface Area at the Receiving Site of a FTSG Via Histogram Planimetry
Histogram planimetry is more accessible than automated analysis software programs, and it is based on the pixel count of a selected irregular area which is divided by the pixel count of 1 cm2 to find a result in terms of cm2 or mm2.
Measured: 7 days post-surgery

Secondary outcomes (4)

Rate of Successful (Completely Healed) Graft in Response to Treatment With 0.25% Topical Timolol Gel Versus SOC Using a Blinded Physician Assessment Score at the Receiving Site of a FTSG at 7 Days
Physician blinded to subject's treatment group uses VSS which documents scar appearance change over time via photos. VSS ranges from 0 (most desirable outcome) to 13 (least desirable). A lower score is considered a better outcome and a higher score is a worse outcome. VSS consists of 4 sub-scales, with each reporting a value. The "pigmentation" ranges from 0 (normal pigment) to 2 (hyperpigment); "vascularity" ranges from 0 (normal appearance) to 3 (purple appearance); "pliability" ranges from 0 (normal) to 5 (contracture); "height" ranges from 0 (normal/flat) to 3 (>5mm). Sub-scale scores are combined to give an overall VSS score.
Measured: 7 days post-surgery
Patient Discomfort During the Healing Process by Means of a Patient Pain VAS
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, and any complaints about how painful they sites are, and how itchy they feel. The score ranges from 1 to 10. A lower score is considered to have a better outcome and a higher score is considered a worse outcome.
Measured: 7 days' post-surgery
Number of Participants With Side Effects Associated With 0.25% Timolol Gel Versus SOC Via Physician Assessment
A physician will 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.
Measured: 7 days' post-surgery
Number of Participants With Side Effects Associated With 0.25% Timolol Gel Versus SOC Via Patient Assessment
Patients will report any side effects they experience post-surgery
Measured: 7 days' post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 201910 Jan 2022

First posted6 Jul 2018
Study start2 Jan 2019
Primary completion10 Jan 2022
Study completion10 Jan 2022

Why it stopped: Due to the insufficient accrual rate and strategic reasons to focus our efforts on higher impact research projects.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Wound of SkinStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The protocol will begin post-surgery. Eligible subjects will be assigned by computer-based randomization to case (0.25% timolol gel) or control (standard of care \[SOC\]) group and treated as follows: Receiving site of FTSG/case group: 1. During surgery: application of 0.25% timolol gel (2 drops per cm2) on wound bed before FTSG is placed 2. During surgery: application of 0.25% timolol gel (2 drops per cm2) over FTSG after insetting of the graft 3. After bolster removal (7 days): daily cleansing and daily 0.25% timolol (2 drops per cm2) application for 4 weeks Receiving site of FTSG/control group: 1. FTSG surgery as per SOC 2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03579160
Sponsor's protocol ID: BWHMDSC003
Acronym: FTSG
Status last verified: Mar 2026
First submitted: 7 Jun 2018
Last updated: 9 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes: A Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT03579160
Acronym / sponsor ID: FTSG / BWHMDSC003
Conditions: Wound of Skin, Wound Heal, Surgical Wound, Full Thickness Skin Graft Healing
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the insufficient accrual rate and strategic reasons to focus our efforts on higher impact research projects.
Enrolment: 10 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Study start: 2 Jan 2019 (actual)
Primary completion: 10 Jan 2022 (actual)
Study completion: 10 Jan 2022 (actual)
First posted: 6 Jul 2018 (actual)
Results: Posted 9 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To assess the efficacy and safety of topically applied 0.25% timolol gel in promoting wound healing in FTSG receiving site versus standard of care (SOC) by:

Evaluating healing in response to treatment with 0.25% topical timolol gel versus SOC in terms of wound surface area and Graft Take Score at the receiving site of a FTSG at 7 and 14 days;
Evaluating cosmetic outcomes of the receiving site of a FTSG in terms of blinded physician (Vancouver Scar Scale, VSS) and patient (Visual Analogue Scale, VAS) assessment at 3 and 6 months' follow up;
Evaluating the need for further scar revision (dermabrasion or pulsed dye laser [PDL]) at the 6-month follow up;
Evaluating patient discomfort during the healing process by means of a patient pain VAS; and
Determining the side effects associated with 0.25% timolol gel versus SOC

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: The protocol will begin post-surgery. Eligible subjects will be assigned by computer-based randomization to case (0.25% timolol gel) or control (standard of care [SOC]) group and treated as follows: Receiving site of FTSG/case group: 1. During surgery: application of 0.25% timolol gel (2 drops per cm2) on wound bed before FTSG is placed 2. During surgery: application of 0.25% timolol gel (2 drops per cm2) over FTSG after insetting of the graft 3. After bolster removal (7 days): daily cleansing and daily 0.25% timolol (2 drops per cm2) application for 4 weeks Receiving site of FTSG/control group: 1. FTSG surgery as per SOC 2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks

Arm	Type	Receives
0.25% Timolol gel applied to full-thickness skin graft	Experimental	Drug: 0.25% timolol gel with full-thickness skin grafts1. During surgery: application of 0.25% timolol gel (2 drops per cm2) on wound bed before FTSG is placed 2. During surgery: application of 0.25% timolol gel (2 drops per cm2) over FTSG after insetting of the graft 3. After bolster removal (7 days): daily cleansing and daily 0.25% timolol (2 drops per cm2) application for 4 weeks
Standard of Care dressings	Active comparator	Other: Vaseline dressing1. FTSG surgery as per SOC 2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age ≥18 years of age
Undergoing a procedure which results in the need of a FTSG
Willing to provide written informed consent

Key exclusion criteria (7 listed)

Age less than 18 years of age
Pregnant women
(Use of systemic drugs that can impede wound healing, such retinoids or immune-suppressive drugs)
Severe coagulation disorders
Severe, uncontrolled systemic comorbidities, such as diabetes, arthritis, etc.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.25% timolol gel with full-thickness skin graftsTimolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.	Drug	0.25% Timolol gel applied to full-thickness skin graft
Vaseline dressingVaseline will be applied to wound bed immediately after surgery before dressing is applied.	Other	Standard of Care dressings

Primary outcome

Healed Wound Surface in Response to Treatment With 0.25% Topical Timolol Gel Versus SOC in Terms of Wound Surface Area at the Receiving Site of a FTSG Via Histogram Planimetry
Time frame: 7 days post-surgery
Histogram planimetry is more accessible than automated analysis software programs, and it is based on the pixel count of a selected irregular area which is divided by the pixel count of 1 cm2 to find a result in terms of cm2 or mm2.

4 secondary outcomes

Rate of Successful (Completely Healed) Graft in Response to Treatment With 0.25% Topical Timolol Gel Versus SOC Using a Blinded Physician Assessment Score at the Receiving Site of a FTSG at 7 Days
Time frame: 7 days post-surgery
Patient Discomfort During the Healing Process by Means of a Patient Pain VAS
Time frame: 7 days' post-surgery
Number of Participants With Side Effects Associated With 0.25% Timolol Gel Versus SOC Via Physician Assessment
Time frame: 7 days' post-surgery
Number of Participants With Side Effects Associated With 0.25% Timolol Gel Versus SOC Via Patient Assessment
Time frame: 7 days' post-surgery

Results and safety

Results posted to the registry on 9 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.25% Timolol Gel Applied to Full-thickness Skin Graft	4	3
Standard of Care Dressings	6	5

Primary outcome: Healed Wound Surface in Response to Treatment With 0.25% Topical Timolol Gel Versus SOC in Terms of Wound Surface Area at the Receiving Site of a FTSG Via Histogram Planimetry

Time frame: 7 days post-surgery. Count of participants. Unit: Participants

Measure	0.25% Timolol Gel Applied to Full-thickness Skin Graft n = 0	Standard of Care Dressings n = 0
Value	0	0

Population analysed: Data not collected per histoplanimetry method of analysis due to the absence of a required calibration reference at the time of image capture. Histoplanimetry relies on accurate calibration to ensure that measurements taken from the wound images are consistent, reliable, and reproducible. Data is not available now nor will it be available in the future.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: over 7 days, the duration of the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.25% Timolol Gel Applied to Full-thickness Skin Graft	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Standard of Care Dressings	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healed Wound Surface in Response to Treatment With 0.25% Topical Timolol Gel Versus SOC in Terms of Wound Surface Area at the Receiving Site of a FTSG Via Histogram Planimetry (time frame: 7 days post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579160.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.