Scars
Conditions
Brief summary
Multicenter, double-blind study comparing SLI-F06 to vehicle formulation buffer for the improvement in scar appearance and wound strength in routine surgical excisions, as well as post-operative abdominoplasty scar appearance.
Detailed description
The study is divided into 2 parts where Part A is a Phase I safety/proof of concept study of small scars pre-abdominoplasty, and Part B is a Phase IIa study of post-abdominoplasty scars. In Part A of the study, subjects will have their abdominoplasty site mapped to accommodate a series of excisions depending on pannus size. All excisions to be treated with SLI-F06 will be on one side of the mapped area (i.e., left side or right side) and vehicle treated excisions will be on the other side of the mapped area. At time of abdominoplasty the excision site will be harvested and processed. In Part B of the study, subjects who complete Part A will be randomly assigned to receive injections of SLI-F06 along one half (left or right) of the abdominoplasty incision and control injections along the other half. The subject will undergo routine wound care and will attend study follow-up visits following abdominoplasty. The entire incision will be treated post-operatively in precisely the same manner. Duration of study-approximately 26 months.
Interventions
DRUGSLI-F06
Active treatment
Placebo treatment
Sponsors
ethica Clinical Research Inc.
Scarless Laboratories, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test (UPT) at Visit 1a and 1b and practice a reliable method of contraception throughout the study. 2. Seeking or scheduled for standard elective abdominoplasty. 3. Willing to undergo directed excisions and follow-up prior to abdominoplasty and to undergo all follow-up visits after abdominoplasty. 4. Willing to undergo directed excisions under local anesthetic 5. Be able to follow study instructions and likely to complete all required visits. 6. Sign the Institutional Review Board (IRB)-approved Informed Consent Form (ICF), which includes the Photographic Release Form and HIPAA, prior to any study-related procedures being performed.
Exclusion criteria
1. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control. 2. Known hypersensitivity or previous allergic reaction to any constituent of the investigational product (IP). 3. History of diabetes mellitus or a Hemoglobin (HgB) A1C greater than 5.7 percent. 4. Morbid obesity (i.e., BMI \>40). 5. History of prior abdominal surgery. 6. History of abdominal liposuction, cryolipolysis, focused ultrasound or other fat reduction procedures in or near the anterior abdomen within 12 months of baseline. 7. History of poor or delayed wound healing such as a prior wound dehiscence, chronic wound or leg ulcer. 8. History of or evidence of a genetic collagen disorder such as Ehlers-Danlos syndrome. 9. Operating Physician unable to design an abdominoplasty incision area of at least 25 cm wide by 12 cm tall at the center of the fusiform. 10. The presence of any abnormality of the skin within the area of the proposed abdominoplasty that, in the opinion of the Principal Investigator (PI), could interfere with the excision process or grading of the resultant surgical scar. 11. Use of any restricted concomitant medications/procedures or tobacco/inhaled nicotine products within a restricted time period. 12. Allergy to or intolerance of local anesthetics. 13. Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with interpretation of study results or compliance of the subject and, in the opinion of the PI, would make the subject inappropriate for study entry. 14. Any personal, familial, employment or financial situation that could impede the subject's ability to attend all study visits and successfully complete the entire clinical study. 15. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. 16. Exposure to any other investigational drug/device within 30 days prior to study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment | Post-excision at Month 3 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 10.2 |
| BMI | 32 kg/m^2 STANDARD_DEVIATION 5.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 14 / 22 | 14 / 22 |
| serious Total, serious adverse events | 3 / 22 | 3 / 22 |
Outcome results
Primary
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment
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.
Time frame: Post-excision at Month 3
Population: Part A: Pre-abdominoplasty excisions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SLI-F06 | Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment | 4.4 score on a scale | Standard Deviation 1.7 |
| Formulation Buffer | Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment | 4.5 score on a scale | Standard Deviation 1.7 |
Primary
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment
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.
Time frame: Post-abdominoplasty at Month 12
Population: Part B: Abdominoplasty incisions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SLI-F06 | Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment | 1.6 score on a scale | Standard Deviation 1.7 |
| Formulation Buffer | Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment | 1.7 score on a scale | Standard Deviation 1.7 |