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Table 4 Treatment-related adverse eventsa (safety population)

From: 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)

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 infectionb 0 4 (4.6)
 Skin infectionb 0 3 (3.4)
 Dermatitisc 0 2 (2.3)
 Maculopapular rashd 0 2 (2.3)
  1. AE adverse event
  2. aAEs were deemed unrelated, possibly, probably, or definitely related to treatment by the investigator
  3. bStaphylococcal skin infection was confirmed with either microbiology sample or antibiotic treatment, and skin infection included all unspecified skin infection
  4. cDescribed as dermatitis without pruritus or pain (n = 1) and lumber area skin inflammation (n = 1)
  5. dPatients with maculopapular rash are different from those with dermatitis