ScarsPhase 1/2NCT03880058
Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance
A Phase 1/2 study testing SLI-F06 and Formulation buffer in people with Scars, run by Scarless Laboratories, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scars
- What is being tested?
- SLI-F06 and Formulation buffer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Mar 2019to 18 May 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Seeking or scheduled for standard elective abdominoplasty.
- Willing to undergo directed excisions and follow-up prior to abdominoplasty and to undergo all follow-up visits after abdominoplasty.
- Willing to undergo directed excisions under local anesthetic
- Be able to follow study instructions and likely to complete all required visits.
- 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.
Who cannot join
- Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
- Known hypersensitivity or previous allergic reaction to any constituent of the investigational product (IP).
- History of diabetes mellitus or a Hemoglobin (HgB) A1C greater than 5.7 percent.
- Morbid obesity (i.e., BMI >40).
- History of prior abdominal surgery.
- History of abdominal liposuction, cryolipolysis, focused ultrasound or other fat reduction procedures in or near the anterior abdomen within 12 months of baseline.
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- History of poor or delayed wound healing such as a prior wound dehiscence, chronic wound or leg ulcer.
- History of or evidence of a genetic collagen disorder such as Ehlers-Danlos syndrome.
- 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.
- 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.
- Use of any restricted concomitant medications/procedures or tobacco/inhaled nicotine products within a restricted time period.
- Allergy to or intolerance of local anesthetics.
- 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.
- 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.
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- Exposure to any other investigational drug/device within 30 days prior to study entry.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site 3
Bala-Cynwyd, Pennsylvania, 19004
Site 1
Chicago, Illinois, 60611-2950
Site 2
St Louis, Missouri, 63110
About this study
Official title: Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions and Post-Operative Scar Appearance In Subjects Undergoing Abdominoplasty
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.
Read the 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.
- Conditions
- Scars
- Being tested
- SLI-F06, Formulation buffer
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLI-F06Drug
Also called F06-C40
Active treatment
Formulation bufferDrug
Also called Placebo, vehicle
Placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| SLI-F06 | Active comparator | Drug Product under investigation Receives: Drug: SLI-F06 |
| Formulation Buffer | Placebo comparator | Placebo Receives: Drug: Formulation buffer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-excision at Month 3
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.
Measured: Post-abdominoplasty at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start3 Mar 2019
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scarless Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Responsible party
- Sponsor
- Investigators
- Robert D. Galiano, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880058
- Sponsor's protocol ID
- SLI-C40-001
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2019
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions and Post-Operative Scar Appearance In Subjects Undergoing Abdominoplasty
- ClinicalTrials.gov ID
- NCT03880058
- Acronym / sponsor ID
- SLI-C40-001
- Conditions
- Scars
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Scarless Laboratories, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLI-F06 | Active comparator | Drug: SLI-F06Drug Product under investigation |
| Formulation Buffer | Placebo comparator | Drug: Formulation bufferPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Seeking or scheduled for standard elective abdominoplasty.
- Willing to undergo directed excisions and follow-up prior to abdominoplasty and to undergo all follow-up visits after abdominoplasty.
- Willing to undergo directed excisions under local anesthetic
- Be able to follow study instructions and likely to complete all required visits.
Key exclusion criteria (16 listed)
- Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
- Known hypersensitivity or previous allergic reaction to any constituent of the investigational product (IP).
- History of diabetes mellitus or a Hemoglobin (HgB) A1C greater than 5.7 percent.
- Morbid obesity (i.e., BMI >40).
- History of prior abdominal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLI-F06Also: F06-C40Active treatment | Drug | SLI-F06 |
| Formulation bufferAlso: Placebo, vehiclePlacebo treatment | Drug | Formulation Buffer |
Primary outcome
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment
Time frame: 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.
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment
Time frame: Post-abdominoplasty at Month 12
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D. Galiano, MD principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SLI-F06 and Formulation buffer in people with Scars, run by Scarless Laboratories, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment (time frame: Post-excision at Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.