Trial Outcomes & Findings for Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes (NCT NCT03579160)
NCT ID: NCT03579160
Last Updated: 2026-06-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
10 participants
Primary outcome timeframe
7 days post-surgery
Results posted on
2026-06-09
Participant Flow
Participant milestones
| Measure |
0.25% Timolol Gel Applied to Full-thickness Skin Graft
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
0.25% timolol gel with full-thickness skin grafts: Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.
|
Standard of Care Dressings
1. FTSG surgery as per SOC
2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks
Vaseline dressing: Vaseline will be applied to wound bed immediately after surgery before dressing is applied.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
0.25% Timolol Gel Applied to Full-thickness Skin Graft
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
0.25% timolol gel with full-thickness skin grafts: Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.
|
Standard of Care Dressings
1. FTSG surgery as per SOC
2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks
Vaseline dressing: Vaseline will be applied to wound bed immediately after surgery before dressing is applied.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
1 participant withdrew from study
Baseline characteristics by cohort
| Measure |
0.25% Timolol Gel Applied to Full-thickness Skin Graft
n=3 Participants
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
0.25% timolol gel with full-thickness skin grafts: Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.
|
Standard of Care Dressings
n=5 Participants
1. FTSG surgery as per SOC
2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks
Vaseline dressing: Vaseline will be applied to wound bed immediately after surgery before dressing is applied.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
82 years
STANDARD_DEVIATION 13.86 • n=3 Participants
|
76.2 years
STANDARD_DEVIATION 13.59 • n=5 Participants
|
78.37 years
STANDARD_DEVIATION 11.57 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants • 1 participant withdrew from study
|
2 Participants
n=5 Participants • 1 participant withdrew from study
|
2 Participants
n=8 Participants • 1 participant withdrew from study
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants • 1 participant withdrew from study
|
3 Participants
n=5 Participants • 1 participant withdrew from study
|
6 Participants
n=8 Participants • 1 participant withdrew from study
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
5 participants
n=5 Participants
|
8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 7 days post-surgeryPopulation: 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.
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.
Outcome measures
| Measure |
0.25% Timolol Gel Applied to Full-thickness Skin Graft
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
0.25% timolol gel with full-thickness skin grafts: Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.
|
Standard of Care Dressings
1. FTSG surgery as per SOC
2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks
Vaseline dressing: Vaseline will be applied to wound bed immediately after surgery before dressing is applied.
|
|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days post-surgeryPhysician 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.
Outcome measures
| Measure |
0.25% Timolol Gel Applied to Full-thickness Skin Graft
n=3 Participants
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
0.25% timolol gel with full-thickness skin grafts: Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.
|
Standard of Care Dressings
n=5 Participants
1. FTSG surgery as per SOC
2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks
Vaseline dressing: Vaseline will be applied to wound bed immediately after surgery before dressing is applied.
|
|---|---|---|
|
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
|
2 score on a scale
Standard Deviation 0
|
0.5 score on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: 7 days' 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, 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.
Outcome measures
| Measure |
0.25% Timolol Gel Applied to Full-thickness Skin Graft
n=3 Participants
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
0.25% timolol gel with full-thickness skin grafts: Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.
|
Standard of Care Dressings
n=5 Participants
1. FTSG surgery as per SOC
2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks
Vaseline dressing: Vaseline will be applied to wound bed immediately after surgery before dressing is applied.
|
|---|---|---|
|
Patient Discomfort During the Healing Process by Means of a Patient Pain VAS
|
3.33 score on a scale
Standard Deviation 1.15
|
2.83 score on a scale
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: 7 days' post-surgeryA 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.
Outcome measures
| Measure |
0.25% Timolol Gel Applied to Full-thickness Skin Graft
n=3 Participants
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
0.25% timolol gel with full-thickness skin grafts: Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.
|
Standard of Care Dressings
n=5 Participants
1. FTSG surgery as per SOC
2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks
Vaseline dressing: Vaseline will be applied to wound bed immediately after surgery before dressing is applied.
|
|---|---|---|
|
Number of Participants With Side Effects Associated With 0.25% Timolol Gel Versus SOC Via Physician Assessment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days' post-surgeryPatients will report any side effects they experience post-surgery
Outcome measures
| Measure |
0.25% Timolol Gel Applied to Full-thickness Skin Graft
n=3 Participants
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
0.25% timolol gel with full-thickness skin grafts: Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.
|
Standard of Care Dressings
n=5 Participants
1. FTSG surgery as per SOC
2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks
Vaseline dressing: Vaseline will be applied to wound bed immediately after surgery before dressing is applied.
|
|---|---|---|
|
Number of Participants With Side Effects Associated With 0.25% Timolol Gel Versus SOC Via Patient Assessment
|
0 Participants
|
0 Participants
|
Adverse Events
0.25% Timolol Gel Applied to Full-thickness Skin Graft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Dressings
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
BWH Dermatology Research Project Coordinator
Brigham and Women's Hospital
Phone: 617-264-5696
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place