Prospective Placebo-controlled Study of Synochi Scar Spray

NCT05138107 | Unknown

• 1 other identifier: SYNSS_02
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Burns Multiple

Keywords

autologous skin transplant; appearance

Outcome Measures

Primary Outcomes (1)

• 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

  12 month study time frame

Secondary Outcomes (1)

• evaluate the safety of Synochi Scar Spray

  12 month study time frame

Study Arms (2)

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.

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.

Other: Synochi Scar Spray Placebo

Interventions

Synochi Scar Spray Cosmetic OTHER

Application of the cosmetic on each skin graft in a blinded fashion in different sections for a 9 month duration.

Skin Graft Burn Patients Experimental Site

Synochi Scar Spray Placebo OTHER

Application of the placebo on each skin graft in a blinded fashion in different sections for a 9 month duration.

Skin Graft Burn Patients Placebo Site

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.
• 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).

Sponsors & Collaborators

• Synochi, LLC: lead
• LAC+USC Medical Center: collaborator

Study Officials

• Justin Gillenwater, MD

  USC School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Gillenwater, MD

CONTACT

(323)409-7750; Justin.Gillenwater@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 30, 2021
• Study Start: July 1, 2022
• Primary Completion: May 17, 2024
• Study Completion: July 17, 2025
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share