Table 11. Clinical trials of epicutaneous immunotherapy.

Design & reference	Sample: size & age	Protocol: duration & daily maintenance dose	Outcome (by ITT) and other significant findings	Notable adverse events
Milk EPIT vs placebo, RCT	10 active 9 placebo	3 months of 3 48-hour applications per week, 1 mg	Milk EPIT resulted in a non-significant increase in mean maximum tolerated dose from 1.8 mL to 28 mL (P=0.18), with good safety profile	Local AE in 4 active subjects vs 2 placebo; 24 systemic AE in active group, vs 8 in placebo No anaphylaxis or EAI
Dupont et al. 2010	10 months–8 years
Peanut EPIT vs placebo, RCT	49 active 20 placebo	2 weeks with 4 different patch doses, 20 500 μg	2 weeks peanut EPIT was safe and well tolerated	2 systemic reactions; no severe AE and no EAI
Jones et al. 2016	5–50 years
Peanut EPIT vs placebo, RCT	49 active 25 placebo	52 weeks, 100 or 250 μg	47% of active tolerated 5 g OFC or had 10-fold increase in successfully consumed dose, vs 15% in placebo. Treatment success more likely in <11 years	Reactions extending beyond patch site occurred in 0.1% active, one with systemic hives
Jones et al. 2017	4–25 years
Peanut EPIT vs placebo, RCT	10 active 6 placebo	52 weeks, 250 μg	35.3% of active vs 13.6% of placebo demonstrated significant response. Mean cumulative reactive dose of 44 mg in active vs 144 mg placebo, with significant increase from baseline (P<0.001)	4 treatment-related serious AE in 3 active subjects; no severe anaphylaxis. 1.1% drop-out rate due to treatment-emergent AE
Preliminary results released Oct 2017	4–11 years

AE, adverse event; EAI, epinephrine auto-injector; EPIT, epicutaneous immunotherapy; ITT, intention to treat; OFC, oral food challenge; RCT, randomized controlled trial; SU, sustained unresponsiveness.