Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study)

Table 4 Treatment-related adverse events^a (safety population)

n (%)	SD-101 6% n = 82	Vehicle n = 87
Any treatment-related AE	15 (18.3)	19 (21.8)
Treatment-Related AEs Occurring in ≥2% of Patients in Either Treatment Arm
Pruritus (localized or generalized)	6 (7.3)	5 (5.7)
Wound	2 (2.4)	2 (2.3)
Blister	2 (2.4)	2 (2.3)
Urticaria	2 (2.4)	0
Dry skin	2 (2.4)	0
Generalized pruritus	2 (2.4)	0
Staphylococcal skin infection^b	0	4 (4.6)
Skin infection^b	0	3 (3.4)
Dermatitis^c	0	2 (2.3)
Maculopapular rash^d	0	2 (2.3)

AE adverse event
^aAEs were deemed unrelated, possibly, probably, or definitely related to treatment by the investigator
^bStaphylococcal skin infection was confirmed with either microbiology sample or antibiotic treatment, and skin infection included all unspecified skin infection
^cDescribed as dermatitis without pruritus or pain (n = 1) and lumber area skin inflammation (n = 1)
^dPatients with maculopapular rash are different from those with dermatitis

ISSN: 1750-1172