SN514-066b Enzyme in Deep Partial Thickness Burns (NCT06628037) | Clinical Trial Compass
By InvitationPhase 1/2
SN514-066b Enzyme in Deep Partial Thickness Burns
United States27 participantsStarted 2025-05-08
Plain-language summary
This study will examine the tolerability of a gel formulation of the enzyme SN514 in patients with burns suitable for enzymatic debridement. In a rising dose fashion by sequential cohort, concentrations of 0.1%, 0.2%, 0.4% and 0.8% will be tested. Groups of 3 will undergo daily debridement for up to 7 days. Extent of debridement and adverse signs and symptoms will be recorded daily. Dose escalation will stop if a dose level is found to be intolerable. Dose escalation may accelerate if a tested dose is entirely ineffective. There is no placebo control as all burn wounds require debridement.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Thermal burns caused by fire/flame, scalds or contact
✓. Total burns area available for treatment is 25 to 500 cm2 (a larger area may be burned, but the treatment area must be limited to the stated size, and the treatment area must be exclusive of face, hands, genitalia and sites deemed to be at high risk for developing compartment syndrome)
✓. Target burns for treatment is deep partial thickness (DPT) in depth
Exclusion criteria
✕. Subject has another life threatening traumatic injury
✕. Patient's proposed study wound site has any of the following conditions:
✕. Cardio-pulmonary disease (MI within 6 months prior to injury, severe or unstable ischemic heart disease, severe or unstable heart failure, severe pulmonary hypertension, severe COPD or pre-existing oxygen-dependent pulmonary diseases, severe broncho-pneumonia within 1 month prior to injury, steroid dependent asthma, or uncontrolled asthma)
What they're measuring
1
Determine the maximum tolerated concentration of SN514 gel when applied topically to deep partial thickness burn wounds
✕. Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe circulatory edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins)
✕. Any conditions that would preclude safe treatment or adding further risk to the basic acute burn trauma (such as severe immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, severe cardiovascular disorder, significant pulmonary disorder, significant liver disorder including post alcoholic abuse impaired function or neoplastic disease, blast injury)