Synochi, LLC
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
Burns Multiple
Synochi Scar Spray Cosmetic
Synochi Scar Spray Placebo
Not Applicable
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 Type : | Interventional |
Estimated Enrollment : | 28 participants |
Masking : | Triple |
Masking Description : | blinded |
Primary Purpose : | Supportive Care |
Official Title : | Prospective Placebo-controlled Study of Synochi Scar Spray |
Actual Study Start Date : | July 1, 2022 |
Estimated Primary Completion Date : | May 17, 2024 |
Estimated Study Completion Date : | July 17, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Skin Graft Burn Patients Experimental Site 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 |
Placebo Comparator: Skin Graft Burn Patients Placebo Site 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 |
Ages Eligible for Study: | 22 Years to 50 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.