Trial Outcomes & Findings for Efficacy and Safety of 0.25% Timolol Gel in Healing Surgical Open Wounds (NCT NCT03452072)
NCT ID: NCT03452072
Last Updated: 2026-05-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
87 participants
Primary outcome timeframe
30 days' post-surgery
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
0.25% Timolol Gel Under the Paraffin Gauzes
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)
0.25% Timolol gel with paraffin gauze dressings: 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
|
Standard of Care 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)
Vaseline 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
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
0.25% Timolol Gel Under the Paraffin Gauzes
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)
0.25% Timolol gel with paraffin gauze dressings: 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
|
Standard of Care 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)
Vaseline 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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
14 patients were lost to follow up, did not apply the drug/control. After attempts of contacting them, they still did not send pictures, implying withdrawal from study. Subjects tend to neglect their follow up appointments if they have no active complaints. As most of the wounds heal without complications, some subjects may not feel the importance of follow ups. 2 were found ineligible 4 withdrew consent
Baseline characteristics by cohort
| Measure |
0.25% Timolol Gel Under the Paraffin Gauzes
n=44 Participants
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)
0.25% Timolol gel with paraffin gauze dressings: 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
|
Standard of Care Dressings
n=43 Participants
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)
Vaseline 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
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.26 years
STANDARD_DEVIATION 10.20 • n=34 Participants • 14 patients were lost to follow up, did not apply the drug/control. After attempts of contacting them, they still did not send pictures, implying withdrawal from study. Subjects tend to neglect their follow up appointments if they have no active complaints. As most of the wounds heal without complications, some subjects may not feel the importance of follow ups. 2 were found ineligible 4 withdrew consent
|
70.82 years
STANDARD_DEVIATION 8.36 • n=33 Participants • 14 patients were lost to follow up, did not apply the drug/control. After attempts of contacting them, they still did not send pictures, implying withdrawal from study. Subjects tend to neglect their follow up appointments if they have no active complaints. As most of the wounds heal without complications, some subjects may not feel the importance of follow ups. 2 were found ineligible 4 withdrew consent
|
70.44 years
STANDARD_DEVIATION 9.82 • n=67 Participants • 14 patients were lost to follow up, did not apply the drug/control. After attempts of contacting them, they still did not send pictures, implying withdrawal from study. Subjects tend to neglect their follow up appointments if they have no active complaints. As most of the wounds heal without complications, some subjects may not feel the importance of follow ups. 2 were found ineligible 4 withdrew consent
|
|
Sex: Female, Male
Female
|
20 Participants
n=44 Participants
|
15 Participants
n=43 Participants
|
35 Participants
n=87 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=44 Participants
|
28 Participants
n=43 Participants
|
52 Participants
n=87 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
44 participants
n=44 Participants
|
43 participants
n=43 Participants
|
87 participants
n=87 Participants
|
PRIMARY outcome
Timeframe: 30 days' post-surgeryPopulation: The timolol group enrolled 44, but 9 were excluded from analysis because subjects did not provide pictures at 30 days. The control group enrolled 43, but 5 were excluded from analysis because subjects did not provide pictures at 30 days
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.
Outcome measures
| Measure |
0.25% Timolol Gel Under the Paraffin Gauzes
n=35 Participants
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)
0.25% Timolol gel with paraffin gauze dressings: 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
|
Standard of Care Dressings
n=38 Participants
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)
Vaseline 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
|
9 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 3 months' post-surgeryA 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.
Outcome measures
| Measure |
0.25% Timolol Gel Under the Paraffin Gauzes
n=34 Participants
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)
0.25% Timolol gel with paraffin gauze dressings: 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
|
Standard of Care Dressings
n=33 Participants
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)
Vaseline 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
|
|---|---|---|
|
Cosmetic Outcomes of Open Surgical Wound Healing by Blinded Physician Vancouver Scar Scale Assessment
|
8.8 score on a scale
Standard Deviation 1.6
|
8.8 score on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 6 months' post-surgerySubjects 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.
Outcome measures
| Measure |
0.25% Timolol Gel Under the Paraffin Gauzes
n=34 Participants
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)
0.25% Timolol gel with paraffin gauze dressings: 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
|
Standard of Care Dressings
n=33 Participants
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)
Vaseline 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
|
|---|---|---|
|
Study Subject Complete the Patient Scar Assessment Via Visual Analogue Scale
|
5.71 score on a scale
Standard Deviation 4.44
|
5.97 score on a scale
Standard Deviation 4.34
|
SECONDARY outcome
Timeframe: Up to 6 months' post-surgeryPatients 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.
Outcome measures
| Measure |
0.25% Timolol Gel Under the Paraffin Gauzes
n=34 Participants
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)
0.25% Timolol gel with paraffin gauze dressings: 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
|
Standard of Care Dressings
n=33 Participants
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)
Vaseline 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 Whose Side Effects Are Associated With 0.25% Topical Timolol for Open Surgical Wounds
|
1 Participants
|
0 Participants
|
Adverse Events
Standard of Care Dressings
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.25% Timolol Gel Under the Paraffin Gauzes
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care Dressings
n=43 participants at risk
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)
Vaseline 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
|
0.25% Timolol Gel Under the Paraffin Gauzes
n=44 participants at risk
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)
0.25% Timolol gel with paraffin gauze dressings: 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
|
|---|---|---|
|
Nervous system disorders
Temporary tinnitus, nausea and headache
|
0.00%
0/43 • 6 months
|
2.3%
1/44 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place