Wound HealPhase 2NCT05114239
Topical Timolol: a Comparison of Surgical Outcomes
A Phase 2 study testing Timolol 0.25% Ophthalmic Solution and Standard Wound Care in people with Wound Heal, run by Keith G. LeBlanc, Jr, MD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- Timolol 0.25% Ophthalmic Solution and Standard Wound Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2021to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- skin wounds greater than or equal to 4cm, closed primarily and linearly following standard excision or Mohs
Who cannot join
- Past medical history of psoriasis
- known history of sensitivity to beta blockers or topical timolol
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Skin Surgery Centre
Metairie, Louisiana, 70005
Taylor G Dickerson, MD, 225-955-3679, tgrif3@lsuhsc.edu
Keith Leblanc, MD, 504-644-4226, kleb12@lsuhsc.edu
About this study
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.
Read the detailed description
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:
- Evaluating cosmetic outcomes of surgical wounds in terms of blinded physician and patient assessment at 30 days and 90days following suture removal
- Evaluating patient discomfort by patient questionnaire.
- Determining the side effects associated to 0.25% topical timolol versus SOC;
- Conditions
- Wound Heal
- Being tested
- Timolol 0.25% Ophthalmic Solution, Standard Wound Care
- Keywords
- Timolol, Wound healing, Surgical Wounds
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol 0.25% Ophthalmic SolutionDrug
Applied to treatment side prior to standard wound care
Standard Wound CareOther
Wound is washed twice a day with soap and then petrolatum and a bandage is applied.
| Study group | Role | What they receive |
|---|---|---|
| Timolol | Experimental | Timolol 0.25% applied to distal or posterior half of wound edge twice daily prior and adjunct to prior wound care. Receives: Drug: Timolol 0.25% Ophthalmic Solution |
| Standard Wound Care | Placebo comparator | Petrolatum ointment Receives: Other: Standard Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed cosmetic difference of scar in treatment side versus control: Yes or no
Photo review of objective cosmetic difference by blinded physician
Measured: 1 month after suture removal
Observed cosmetic difference of scar in treatment side versus control: Yes or no
Photo review of objective cosmetic difference by blinded physician
Measured: 3 months after suture removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start7 Apr 2021
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keith G. LeBlanc, Jr, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Keith G. LeBlanc, Jr, MD, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Keith G LeBlanc, MD, Principal investigator, LSU HSC New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114239
- Sponsor's protocol ID
- 1227
- Status last verified
- Oct 2021
- First submitted
- 2 Jul 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38261740
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Timolol: a Comparison of Surgical Outcomes
- ClinicalTrials.gov ID
- NCT05114239
- Acronym / sponsor ID
- 1227
- Conditions
- Wound Heal
- Keywords
- Timolol, Wound healing, Surgical Wounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Keith G. LeBlanc, Jr, MDUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- Evaluating cosmetic outcomes of surgical wounds in terms of blinded physician and patient assessment at 30 days and 90days following suture removal
- Evaluating patient discomfort by patient questionnaire.
- Determining the side effects associated to 0.25% topical timolol versus SOC;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol | Experimental | Drug: Timolol 0.25% Ophthalmic SolutionTimolol 0.25% applied to distal or posterior half of wound edge twice daily prior and adjunct to prior wound care. |
| Standard Wound Care | Placebo comparator | Other: Standard Wound CarePetrolatum ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- skin wounds greater than or equal to 4cm, closed primarily and linearly following standard excision or Mohs
Key exclusion criteria (3 listed)
- Past medical history of psoriasis
- known history of sensitivity to beta blockers or topical timolol
- pregnant women
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 |
|---|---|---|
| Timolol 0.25% Ophthalmic SolutionApplied to treatment side prior to standard wound care | Drug | Timolol |
| Standard Wound CareWound is washed twice a day with soap and then petrolatum and a bandage is applied. | Other | Standard Wound Care |
Primary outcome
Observed cosmetic difference of scar in treatment side versus control: Yes or no
Time frame: 1 month after suture removal
Photo review of objective cosmetic difference by blinded physician
Observed cosmetic difference of scar in treatment side versus control: Yes or no
Time frame: 3 months after suture removal
Photo review of objective cosmetic difference by blinded physician
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Derived from this study: PubMed 38261740Jeha 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.
- Individual participant dataSharing planned: No
Related trials for Wound Heal
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Recruiting
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Difficult-to-heal Wounds
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.
Keith G LeBlanc, MD principal investigator
LSU HSC New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Timolol 0.25% Ophthalmic Solution and Standard Wound Care in people with Wound Heal, run by Keith G. LeBlanc, Jr, MD at 1 site in United States.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Nov 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taylor G Dickerson, MD ((504) 568-7110, tgrif3@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed cosmetic difference of scar in treatment side versus control: Yes or no (time frame: 1 month after suture removal). The study lists 2 primary outcomes in all. 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 NCT05114239, which also lists 1 linked publication.
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 Nov 2021.