Trial Outcomes & Findings for Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance (NCT NCT03880058)

Last Updated: 2023-04-18

Results Overview

POSAS is an established scale for assessing scar by both the patient and the observer. The overall opinion of the scar is reported on a scale of 1-10, with 1 being normal skin and 10 being the worst scar. Comparisons between treatment groups for efficacy analyses are based on 95% confidence intervals (CI) calculated using mixed models with treatment group as a fixed effect and subject as a random effect to account for multiple observations (i.e., scars) within subject.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Post-excision at Month 3

Results posted on

2023-04-18

Participant Flow

Unit of analysis: Pre and post abdominoplasty scars

Participant milestones

Participant milestones
Measure	All Study Participants All study participants served as their own control. In Part A, subjects had their abdominoplasty site mapped with equal excisions on left/right of midline to accommodate small (12), medium (14) or large (18) pannus excisions with standardized 3 cm length. In Part B, subjects received injections of SLI-F06 along one half (left/right) of the abdominoplasty incision and control injections along the other half. The solution of SLI-F06 or vehicle solution was injected intradermally into BOTH edges of the surgical wound immediately prior to closure (Part A) and before/after closure (Part B). The concentration of SLI-F06 was 25 mg/ml. In Part A, a total of 0.4 mL (10 mg) was injected once at each excision site. A total of 0.2 mL (5 mg) was injected along EACH SIDE of the wound edge. As each wound edge was 3 cm in length, 0.05 mL was injected per 0.75 cm of wound edge. The total exposure of SLI-F06 for subjects with small pannus was approximately 60 mg (6 treated excisions), for subjects with a medium pannus approximately 70 mg (7 treated excisions), and for subjects with a large pannus approximately 90 mg (9 treated excisions). In Part B of the study, 0.05 mL was injected once per 0.75 cm of wound edge as above. A subject with an incision length of 25 cm (12.5 cm active treatment) was exposed to 41.6 mg of SLI-F06, while subjects with an incision length of 30 cm (15 cm active treatment) or 32 cm (16 cm active treatment) were exposed to 50 mg or 53.3 mg, respectively.
Part A: Pre-abdominoplasty Injections STARTED	22 280
Part A: Pre-abdominoplasty Injections Received SLI-F06	22 140
Part A: Pre-abdominoplasty Injections Received Control	22 140
Part A: Pre-abdominoplasty Injections COMPLETED	22 280
Part A: Pre-abdominoplasty Injections NOT COMPLETED	0 0
Part B: Abdominoplasty Injections STARTED	21 21
Part B: Abdominoplasty Injections Received SLI-F06	21 21
Part B: Abdominoplasty Injections Received Control	21 21
Part B: Abdominoplasty Injections COMPLETED	21 21
Part B: Abdominoplasty Injections NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=22 Participants All study participants served as their own control. In Part A, subjects had their abdominoplasty site mapped with equal excisions on left/right of midline to accommodate small (12), medium (14) or large (18) pannus excisions with standardized 3 cm length. In Part B, subjects received injections of SLI-F06 along one half (left/right) of the abdominoplasty incision and control injections along the other half. The solution of SLI-F06 or vehicle solution was injected intradermally into BOTH edges of the surgical wound immediately prior to closure (Part A) and before/after closure (Part B). The concentration of SLI-F06 was 25 mg/ml. In Part A, a total of 0.4 mL (10 mg) was injected once at each excision site. A total of 0.2 mL (5 mg) was injected along EACH SIDE of the wound edge. As each wound edge was 3 cm in length, 0.05 mL was injected per 0.75 cm of wound edge. The total exposure of SLI-F06 for subjects with small pannus was approximately 60 mg (6 treated excisions), for subjects with a medium pannus approximately 70 mg (7 treated excisions), and for subjects with a large pannus approximately 90 mg (9 treated excisions). In Part B of the study, 0.05 mL was injected once per 0.75 cm of wound edge as above. A subject with an incision length of 25 cm (12.5 cm active treatment) was exposed to 41.6 mg of SLI-F06, while subjects with an incision length of 30 cm (15 cm active treatment) or 32 cm (16 cm active treatment) were exposed to 50 mg or 53.3 mg, respectively.
Age, Continuous	43.4 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 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	6 Participants n=5 Participants
Race (NIH/OMB) White	16 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
BMI	32 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants

PRIMARY outcome

Timeframe: Post-excision at Month 3

Population: Part A: Pre-abdominoplasty excisions

Outcome measures

Outcome measures
Measure	SLI-F06 n=140 Scars Drug Product under investigation SLI-F06: Active treatment	Formulation Buffer n=140 Scars Placebo Formulation buffer: Placebo treatment
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment	4.4 score on a scale Standard Deviation 1.7	4.5 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Post-abdominoplasty at Month 12

Population: Part B: Abdominoplasty incisions

Outcome measures

Outcome measures
Measure	SLI-F06 n=21 Scars Drug Product under investigation SLI-F06: Active treatment	Formulation Buffer n=21 Scars Placebo Formulation buffer: Placebo treatment
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment	1.6 score on a scale Standard Deviation 1.7	1.7 score on a scale Standard Deviation 1.7

Adverse Events

SLI-F06

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Formulation Buffer

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SLI-F06 n=22 participants at risk Drug Product under investigation SLI-F06: Active treatment	Formulation Buffer n=22 participants at risk Placebo Formulation buffer: Placebo treatment
Vascular disorders Pulmonary embolism	4.5% 1/22 • Number of events 1 • Subjects were assessed at Visit 4a (Day 29), Visit 5a (Day 57 - Group 2 only), Visit 6a (Day 85 - Group 1 only), Visits 3b-12b (M1-3, 6, 9, 12, 15, 18, 21 and 24 at study exit). No difference in definition Systematic Assessment: Subjects were questioned for the occurrence of any new or worsening signs or symptoms at each visit. Safety laboratory tests were conducted at select study visits. Clinically significant adverse events were reported.	4.5% 1/22 • Number of events 1 • Subjects were assessed at Visit 4a (Day 29), Visit 5a (Day 57 - Group 2 only), Visit 6a (Day 85 - Group 1 only), Visits 3b-12b (M1-3, 6, 9, 12, 15, 18, 21 and 24 at study exit). No difference in definition Systematic Assessment: Subjects were questioned for the occurrence of any new or worsening signs or symptoms at each visit. Safety laboratory tests were conducted at select study visits. Clinically significant adverse events were reported.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	4.5% 1/22 • Number of events 1 • Subjects were assessed at Visit 4a (Day 29), Visit 5a (Day 57 - Group 2 only), Visit 6a (Day 85 - Group 1 only), Visits 3b-12b (M1-3, 6, 9, 12, 15, 18, 21 and 24 at study exit). No difference in definition Systematic Assessment: Subjects were questioned for the occurrence of any new or worsening signs or symptoms at each visit. Safety laboratory tests were conducted at select study visits. Clinically significant adverse events were reported.	4.5% 1/22 • Number of events 1 • Subjects were assessed at Visit 4a (Day 29), Visit 5a (Day 57 - Group 2 only), Visit 6a (Day 85 - Group 1 only), Visits 3b-12b (M1-3, 6, 9, 12, 15, 18, 21 and 24 at study exit). No difference in definition Systematic Assessment: Subjects were questioned for the occurrence of any new or worsening signs or symptoms at each visit. Safety laboratory tests were conducted at select study visits. Clinically significant adverse events were reported.
Renal and urinary disorders Nephrolithiasis	4.5% 1/22 • Number of events 1 • Subjects were assessed at Visit 4a (Day 29), Visit 5a (Day 57 - Group 2 only), Visit 6a (Day 85 - Group 1 only), Visits 3b-12b (M1-3, 6, 9, 12, 15, 18, 21 and 24 at study exit). No difference in definition Systematic Assessment: Subjects were questioned for the occurrence of any new or worsening signs or symptoms at each visit. Safety laboratory tests were conducted at select study visits. Clinically significant adverse events were reported.	4.5% 1/22 • Number of events 1 • Subjects were assessed at Visit 4a (Day 29), Visit 5a (Day 57 - Group 2 only), Visit 6a (Day 85 - Group 1 only), Visits 3b-12b (M1-3, 6, 9, 12, 15, 18, 21 and 24 at study exit). No difference in definition Systematic Assessment: Subjects were questioned for the occurrence of any new or worsening signs or symptoms at each visit. Safety laboratory tests were conducted at select study visits. Clinically significant adverse events were reported.

Other adverse events

Additional Information

Dr. Elisabeth Leeflang

Scarless Labs Inc.

Phone: 213-788-2128

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place