Trial Outcomes & Findings for Hypertrophic Scar Prevention by Novel Topical Gel Application (NCT NCT03403621)
NCT ID: NCT03403621
Last Updated: 2023-11-22
Results Overview
Number of participants to experience serious adverse events as defined as death \[due to treatment\] or life threatening adverse experience \[due to treatment\], hospitalization \[due to treatment\], persistent or significant disability or incapacity \[due to treatment\], birth defect/anomalies \[due to treatment\] and tissue necrosis \[due to treatment\].
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
4 weeks post-operatively
Results posted on
2023-11-22
Participant Flow
Unit of analysis: Scars
Participant milestones
| Measure |
Topical Pentamidine Isethionate
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Overall Study
STARTED
|
6 6
|
6 6
|
|
Overall Study
COMPLETED
|
4 4
|
4 4
|
|
Overall Study
NOT COMPLETED
|
2 2
|
2 2
|
Reasons for withdrawal
| Measure |
Topical Pentamidine Isethionate
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Hypertrophic Scar Prevention by Novel Topical Gel Application
Baseline characteristics by cohort
| Measure |
All Study Participants
n=6 Participants
All study participants received two treatments: topical pentamidine isethionate and placebo. Participants were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision and placebo on the other end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 15.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-operativelyNumber of participants to experience serious adverse events as defined as death \[due to treatment\] or life threatening adverse experience \[due to treatment\], hospitalization \[due to treatment\], persistent or significant disability or incapacity \[due to treatment\], birth defect/anomalies \[due to treatment\] and tissue necrosis \[due to treatment\].
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeks post-operativelyNumber of participants to experience adverse events as defined as skin infection, skin irritation and wound dehiscence. Skin irritation is scored by local skin reaction (LSR) grading scale. Wound infection is defined by skin that is red, swollen, hot and painful ("calor, dolor, rubor, tumor") \[by clinical exam\] with or without discharge. Wound dehiscence is defined as a measurable breaking open of the surgical incision along the suture.
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Adverse Events
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-operatively) and at postop week 2 and 4.Ultrasound will be used to quantify hypertrophic scar dimensions (length, width and height) and volume size using cm\^3 as the unit of measure.
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Change in Scar Volume
Baseline, 2 weeks post-operative
|
-0.72 cm^3
Standard Deviation 0.50
|
-0.68 cm^3
Standard Deviation 0.52
|
|
Change in Scar Volume
Baseline, 4 weeks post-operative
|
-0.65 cm^3
Standard Deviation 0.77
|
-0.76 cm^3
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline (preoperatively) and 4 weeks post-operatively.Semi-quantitative assessment of scar fibrosis on skin punch biopsy using a scale of none(1) - mild(2) - moderate(3) - severe(4)
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Change in Scar Fibrosis
|
1 units on a scale
Interval 1.0 to 2.0
|
2 units on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline (preoperatively) and 4 weeks post-operatively.Semi-quantitative assessment of scar sclerosis on skin punch biopsy using a scale of none(1) - mild(2) - moderate(3) - severe(4)
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Change in Scar Sclerosis
|
0 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline (preoperatively) and 4 weeks post-operatively.Semi-quantitative assessment of scar angioplasia on skin punch biopsy using a scale of none(1) - mild(2) - moderate(3) - severe(4)
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Change in Scar Angioplasia
|
0 units on a scale
Interval -1.0 to 1.0
|
0 units on a scale
Interval -1.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline (preoperatively) and 4 weeks post-operativelySemi-quantitative assessment of scar relative depth on skin punch biopsy using a scale of Epidermis(1) - Mid-Reticular Dermis (2) - Deep Dermis(3) - Fat(4)
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Change in Scar Relative Depth
|
0 units on a scale
Interval -1.0 to 1.0
|
0 units on a scale
Interval -1.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline (preoperatively) and 4 weeks post-operativelyMeasurement of scar absolute depth on skin punch biopsy reporting in millimeters (mm)
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Change in Scar Absolute Depth
|
-0.17 millimeters
Standard Deviation 2.26
|
1.34 millimeters
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Baseline (preoperatively) and at weeks 2 and 4.The VSS assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. Scale ranges are as follows. Pigmentation (0=normal, 1=hypopigmentation, 2=hyperpigmentation). Height (0=flat, 1=less than 2 mm, 2=2 to 5 mm, 3=greater than 5 mm). Vascularity (0=normal, 1=pink, 2=red, 3=purple). Pliability (0=normal, 1=supple, 2=yielding, 3=firm, 4=banding,5=contracture). Total score can range from 0 to 13, with 0=normal skin, and 13=severe scarring.
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Vancouver Scar Scale (VSS)
Baseline
|
5.5 score on a scale
Standard Deviation 3.7
|
4.8 score on a scale
Standard Deviation 3.6
|
|
Vancouver Scar Scale (VSS)
2 weeks
|
4.0 score on a scale
Standard Deviation 2.2
|
3.5 score on a scale
Standard Deviation 3.2
|
|
Vancouver Scar Scale (VSS)
4 weeks
|
4.8 score on a scale
Standard Deviation 2.3
|
5.8 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline (preoperatively) and at weeks 2 and 4.The patient scar scale assesses pain, itching, color, stiffness, thickness, and irregularity. The scale rates each variable on a scale from 1 (normal skin) to 10 (worst scar imaginable), with a total possible score ranging from 1 (normal) to 120 (worst scar imaginable).
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Patient Scar Assessment Scale (PSAS)
4 weeks
|
25.5 score on a scale
Standard Deviation 14.8
|
27.0 score on a scale
Standard Deviation 11.9
|
|
Patient Scar Assessment Scale (PSAS)
Baseline
|
39 score on a scale
Standard Deviation 8.3
|
43.2 score on a scale
Standard Deviation 9.1
|
|
Patient Scar Assessment Scale (PSAS)
2 weeks
|
27.7 score on a scale
Standard Deviation 6.6
|
28.7 score on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Baseline (preoperatively), 2 weeks, and 4 weeksThe observer scar assessment scale assesses vascularity, pigmentation, thickness, relief, pliability, and surface area. The scale rates each variable on a scale from 1 (normal skin) to 10 (worst scar imaginable), with a total possible score ranging from 1 (normal) to 120 (worst scar imaginable).
Outcome measures
| Measure |
Topical Pentamidine Isethionate
n=6 Participants
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 Participants
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Observer Scar Assessment Scale (OSAS)
Baseline
|
32.3 score on a scale
Standard Deviation 12.8
|
31.2 score on a scale
Standard Deviation 13.7
|
|
Observer Scar Assessment Scale (OSAS)
2 weeks
|
23.5 score on a scale
Standard Deviation 10.1
|
23.3 score on a scale
Standard Deviation 13.0
|
|
Observer Scar Assessment Scale (OSAS)
4 weeks
|
23.2 score on a scale
Standard Deviation 8.6
|
26.3 score on a scale
Standard Deviation 9.9
|
Adverse Events
Topical Pentamidine Isethionate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Control
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topical Pentamidine Isethionate
n=6 participants at risk
Subjects were randomly assigned to apply topical pentamidine isethionate to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments).
Pentamidine Isethionate: Approximately 1.8 mL single dose delivered as topical formulation containing 2% topical pentamidine in silicone-containing base.
|
Placebo Control
n=6 participants at risk
Subjects were randomly assigned to apply topical placebo to either the proximal or distal end of their incision every 48 hours for 4 weeks following surgical scar excision (14-16 treatments). The subject served as their own control.
Placebo: No active ingredient. Approximately 1.8 mL single dose delivered as topical silicone compounding base only.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Itching
|
33.3%
2/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
66.7%
4/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
|
Skin and subcutaneous tissue disorders
Skin flaking
|
33.3%
2/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
33.3%
2/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
|
Skin and subcutaneous tissue disorders
Pustules
|
16.7%
1/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
33.3%
2/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
16.7%
1/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
|
General disorders
Localized pain
|
0.00%
0/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
|
General disorders
Bruising
|
16.7%
1/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
|
Surgical and medical procedures
Wound dehiscence
|
16.7%
1/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study participation for a total of approximately 3 months on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place