| Eligibility |
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 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).
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