Burns MultipleNCT05138107
Prospective Placebo-controlled Study of Synochi Scar Spray
A study testing Synochi Scar Spray Cosmetic in people with Burns Multiple, run by Synochi, LLC.
Trial summary
Randomized, double-blind, placebo controlled, prospective, split-scar study of severe burn victims with autologous skin transplants. 9 months intervention time and 3 months follow-up, photographic scar documentation, self-and observer questionnaires throughout Read more about this study
- Who is it for?
- Ages 22 to 50 years
- Conditions the study is for
- Burns Multiple
- What is being tested?
- Synochi Scar Spray Cosmetic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 17 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Study participants are healthy study participants from any sex and race, but must be between 22 and 50 years of age at the time of consent.
- Study participants must be willing to provide written informed consent and be able to read, write, speak, and understand the test procedures in English. Ability will be documented with a doctors' note.
- Study participants must be willing to sign a Photo and Video Release Form.
- Study participants must possess both the original burn scar area that is the skin graft recipient area and the skin graft donor site that is at least around 6 weeks old that have not been altered in any way prior (No prior scar reduction surgery, laser, steroid injections, silicone sheets or anything of the like).
- Study participants must be in good general health.
Who cannot join
- - Study participants must not currently be under the care of a medical or cosmetic professional for care of the scar to be evaluated in testing.
- They must be without medical diagnosis of medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an organ transplant, a heart murmur, mitral valve prolapse with heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of systemic steroid medication, nasal steroids are permitted), an immunocompromised condition such as AIDS (or HIV positive), lupus, or medicated multiple sclerosis, not pregnant or trying to become pregnant, lactating, transplant recipient on immunosuppression, the BMI should be 19 - < 35.
- Have any type of vascular disease (e.g., arteriosclerosis, Raynaud's Syndrome, or peripheral venous disease) or any blood clotting disorders.
- Have participated in another clinical study within the past 14 days, or be currently participating in another clinical study.
- Have or have someone in their household with known sensitivities or allergies to latex (rubber), bar or liquid cleansing products, serums, moisturizers, lotions, creams, preservatives, fragrances, cosmetics, or common ingredients used in traditional Chinese medicine, including Notopterygium root (Notopterygium Incisum), sweetgum fruit ( Liquidambaris Fructus), bur reed rhizome (Rhizoma Sparganii), corydalis rhizome (Rhizoma Corydalis), ledebouriella root / siler (Radix Saposhnikoviae), costus root (Radix Auklandiae Lappae), rehmannia root (Radix Rehmanniae Preparata), deer horn gelatin/glue (Gelatinum Cornu Cervi), safflower (Carthamus Tinctorius), forsythia fruit (Fructus Forsythiae), red earthworm (Lumbricus), trichosanthes root (Radix Trichosanthes), Chinese motherwort (Herba Leonuri), millettia vine (Caulis Spatholobi), zedoary rhizome (Rhizoma Curcumae), turmeric tuber (Radix Curcumae), rhubarb (Radix et Rhizoma Rhei), white peony root (Radix Paeoniae Alba), white mustard seed (Semen Sinapis Albae), Chinese angelica root (Angelicae sinensis Radix), cinnamon twig (Ramulus Cinnamomi), red peony (Radix Paeoniae Rubra), peach kernel (Semen Persicae), astragalus (Radix Astragali), frankincense resin (Resina Boswelliae Carterii), myrrh (Resina Commiphorae Myrrhae), sandalwood (Santalum Album), radiz notoginseng (Radix Notoginseng), spine of honey locust (Spina Gleditsiae), silkworm (Bombyx Batryticatus)
- Have experienced hives (raised welts) as a reaction to anything contacting their skin.
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- Not be diagnosed with a medical condition that, in the opinion of the Principal Investigator, would preclude participation.
- Not be unwilling to fulfill the performance requirements of the study.
- Not be direct employees, in a relationship with, or family of the sponsor or Principal Investigator.
- Not be participating in any other clinical trial during the time of this clinical trial.
- Medication: Not be receiving any steroid medications (including those used to treat asthma) other than for contraception, hormone therapy, or menopausal purposes. No chemotherapeutic agents or any medication that interferes with wound healing (rheumatologic agents, Emgality or Aimovig).
Trial locations and contacts
No sites are listed yet.
About this study
Randomized, double-blind, placebo controlled, prospective, split-scar study of severe burn victims with autologous skin transplants. 9 months intervention time and 3 months follow-up, photographic scar documentation, self-and observer questionnaires throughout
Read the detailed description
Interventional, comparative, prospective, evaluator blinded, randomized, placebo- controlled, split-scar model longitudinal study including 28-31 healthy study participants (See Section 6 Statistical Considerations) with both the original burn scar area that is the skin graft recipient area and the skin graft donor site.
- Conditions
- Burns Multiple
- Being tested
- Synochi Scar Spray Cosmetic, Synochi Scar Spray Placebo
- Keywords
- autologous skin transplant, appearance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synochi Scar Spray CosmeticOther
Application of the cosmetic on each skin graft in a blinded fashion in different sections for a 9 month duration.
Synochi Scar Spray PlaceboOther
Application of the placebo on each skin graft in a blinded fashion in different sections for a 9 month duration.
| Study group | Role | What they receive |
|---|---|---|
| Skin Graft Burn Patients Experimental Site | Experimental | Both placebo and active cosmetic scar spray will be applied to different parts of the same scar on each participant. The active and the placebo spray will both be applied to the designated area of each scar twice per day. The amount sprayed will cover the designated area of the scar and then be massaged into to scar and surrounding skin with each application. This will be done twice daily for the nine-month duration of the study. Receives: Other: Synochi Scar Spray Cosmetic |
| Skin Graft Burn Patients Placebo Site | Placebo comparator | Both placebo and active cosmetic scar spray will be applied to different parts of the same scar on each participant. The active and the placebo spray will both be applied to the designated area of each scar twice per day. The amount sprayed will cover the designated area of the scar and then be massaged into to scar and surrounding skin with each application. This will be done twice daily for the nine-month duration of the study. Receives: Other: Synochi Scar Spray Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of cosmetic appearance Synochi Scar Spray versus Placebo
Section I of the Patient Scar Assessment Questionnaire (9 questions) minimum 9 points, maximum 36 with higher ratings indicating less improvement of cosmetic appearance
Measured: 12 month study time frame
Secondary outcomes (1)
evaluate the safety of Synochi Scar Spray
Safety of Synochi Scar Spray as indicated by absence of adverse events and/or severe adverse events
Measured: 12 month study time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Jul 2022 (estimated)
- Primary completion17 May 2024 (estimated)
- Study completion17 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns MultipleStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synochi, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LAC+USC Medical Center
- Responsible party
- Sponsor
- Investigators
- Justin Gillenwater, MD, Principal investigator, USC School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138107
- Sponsor's protocol ID
- SYNSS_02
- Status last verified
- Jun 2022
- First submitted
- 9 Nov 2021
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Placebo-controlled Study of Synochi Scar Spray
- ClinicalTrials.gov ID
- NCT05138107
- Acronym / sponsor ID
- SYNSS_02
- Conditions
- Burns Multiple
- Keywords
- autologous skin transplant, appearance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Synochi, LLCIndustry (pharma, biotech, devices)
- Collaborators
- LAC+USC Medical Center
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 17 May 2024 (estimated)
- Study completion
- 17 Jul 2025 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, placebo controlled, prospective, split-scar study of severe burn victims with autologous skin transplants. 9 months intervention time and 3 months follow-up, photographic scar documentation, self-and observer questionnaires throughout
Detailed description
Interventional, comparative, prospective, evaluator blinded, randomized, placebo- controlled, split-scar model longitudinal study including 28-31 healthy study participants (See Section 6 Statistical Considerations) with both the original burn scar area that is the skin graft recipient area and the skin graft donor site.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin Graft Burn Patients Experimental Site | Experimental | Other: Synochi Scar Spray CosmeticBoth placebo and active cosmetic scar spray will be applied to different parts of the same scar on each participant. The active and the placebo spray will both be applied to the designated area of each scar twice per day. The amount sprayed will cover the designated area of the scar and then be massaged into to scar and surrounding skin with each application. This will be done twice daily for the nine-month duration of the study. |
| Skin Graft Burn Patients Placebo Site | Placebo comparator | Other: Synochi Scar Spray PlaceboBoth placebo and active cosmetic scar spray will be applied to different parts of the same scar on each participant. The active and the placebo spray will both be applied to the designated area of each scar twice per day. The amount sprayed will cover the designated area of the scar and then be massaged into to scar and surrounding skin with each application. This will be done twice daily for the nine-month duration of the study. |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - Study participants are healthy study participants from any sex and race, but must be between 22 and 50 years of age at the time of consent.
- Study participants must be willing to provide written informed consent and be able to read, write, speak, and understand the test procedures in English. Ability will be documented with a doctors' note.
- Study participants must be willing to sign a Photo and Video Release Form.
- Study participants must possess both the original burn scar area that is the skin graft recipient area and the skin graft donor site that is at least around 6 weeks old that have not been altered in any way prior (No prior scar reduction surgery, laser, steroid injections, silicone sheets or anything of the like).
- Study participants must be in good general health.
Key exclusion criteria (11 listed)
- - Study participants must not currently be under the care of a medical or cosmetic professional for care of the scar to be evaluated in testing.
- They must be without medical diagnosis of medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an organ transplant, a heart murmur, mitral valve prolapse with heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of systemic steroid medication, nasal steroids are permitted), an immunocompromised condition such as AIDS (or HIV positive), lupus, or medicated multiple sclerosis, not pregnant or trying to become pregnant, lactating, transplant recipient on immunosuppression, the BMI should be 19 - < 35.
- Have any type of vascular disease (e.g., arteriosclerosis, Raynaud's Syndrome, or peripheral venous disease) or any blood clotting disorders.
- Have participated in another clinical study within the past 14 days, or be currently participating in another clinical study.
- Have or have someone in their household with known sensitivities or allergies to latex (rubber), bar or liquid cleansing products, serums, moisturizers, lotions, creams, preservatives, fragrances, cosmetics, or common ingredients used in traditional Chinese medicine, including Notopterygium root (Notopterygium Incisum), sweetgum fruit ( Liquidambaris Fructus), bur reed rhizome (Rhizoma Sparganii), corydalis rhizome (Rhizoma Corydalis), ledebouriella root / siler (Radix Saposhnikoviae), costus root (Radix Auklandiae Lappae), rehmannia root (Radix Rehmanniae Preparata), deer horn gelatin/glue (Gelatinum Cornu Cervi), safflower (Carthamus Tinctorius), forsythia fruit (Fructus Forsythiae), red earthworm (Lumbricus), trichosanthes root (Radix Trichosanthes), Chinese motherwort (Herba Leonuri), millettia vine (Caulis Spatholobi), zedoary rhizome (Rhizoma Curcumae), turmeric tuber (Radix Curcumae), rhubarb (Radix et Rhizoma Rhei), white peony root (Radix Paeoniae Alba), white mustard seed (Semen Sinapis Albae), Chinese angelica root (Angelicae sinensis Radix), cinnamon twig (Ramulus Cinnamomi), red peony (Radix Paeoniae Rubra), peach kernel (Semen Persicae), astragalus (Radix Astragali), frankincense resin (Resina Boswelliae Carterii), myrrh (Resina Commiphorae Myrrhae), sandalwood (Santalum Album), radiz notoginseng (Radix Notoginseng), spine of honey locust (Spina Gleditsiae), silkworm (Bombyx Batryticatus)
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 |
|---|---|---|
| Synochi Scar Spray CosmeticApplication of the cosmetic on each skin graft in a blinded fashion in different sections for a 9 month duration. | Other | Skin Graft Burn Patients Experimental Site |
| Synochi Scar Spray PlaceboApplication of the placebo on each skin graft in a blinded fashion in different sections for a 9 month duration. | Other | Skin Graft Burn Patients Placebo Site |
Primary outcome
improvement of cosmetic appearance Synochi Scar Spray versus Placebo
Time frame: 12 month study time frame
Section I of the Patient Scar Assessment Questionnaire (9 questions) minimum 9 points, maximum 36 with higher ratings indicating less improvement of cosmetic appearance
1 secondary outcome
evaluate the safety of Synochi Scar Spray
Time frame: 12 month study time frame
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- 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.
Justin Gillenwater, MD principal investigator
USC School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Synochi Scar Spray Cosmetic in people with Burns Multiple, run by Synochi, LLC.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Gillenwater, MD ((323)409-7750, Justin.Gillenwater@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of cosmetic appearance Synochi Scar Spray versus Placebo (time frame: 12 month study time frame). 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 16 Jun 2022.