Prospective Placebo-controlled Study of Synochi Scar Spray (NCT05138107) | Clinical Trial Compass
UnknownNot Applicable
Prospective Placebo-controlled Study of Synochi Scar Spray
28 participantsStarted 2022-07-01
Plain-language 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
Who can participate
Age range22 Years – 50 Years
SexALL
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Inclusion Criteria:
* \- 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.
Exclusion Criteria:
* \- 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…
What they're measuring
1
improvement of cosmetic appearance Synochi Scar Spray versus Placebo