BACKGROUND: Health-related quality of life evaluation is scarce in patients with molluscum contagiosum (MC) & little is known about the meaningfulness of lesion count reduction.
METHODS: B-SIMPLE1,2 & 4 Phase 3 trials evaluated the safety & efficacy of once-daily application of berdazimer gel 10.3% or vehicle gel for 12 weeks in patients with MC. Children’s Dermatology Life Quality Index (cDLQI) questionnaires were collected from B-SIMPLE1&2 patients 4 -15 years. MC severity & meaningful change were evaluated in B-SIMPLE4 patients using a 5-point Global Severity (GSA) & 7-point Global Impression of Change (GIC).
RESULTS: cDLQI completed: berdazimer 10.3% or vehicle, B-SIMPLE1 & 2 respectively: n=168 vs 85 & n=185 vs 95. Baseline (BL) mean (median) composite scores: 3.7 (2) vs 3.3 (2) & 3.5 (2) vs 3.5 (2). Reductions from BL after 12 weeks of treatment with berdazimer or vehicle, mean (median): 1.8 (1) vs 1.8 (1) & 1.6 (1) vs 1.9 (1), respectively. Mean (median) reduction from BL of patients with complete clearance (CC) at week 12: 4.3 (3) vs 4.5 (2) & 2.9 (2) vs 3.2 (2), respectively. Reductions for 90% clearance patients were: 3.5 (3) vs 5.6 (2) & 2.8 (2) vs 3.2 (2), respectively. GSA/GIC in B-SIMPLE4. berdazimer: vehicle: n=444 vs 447. Lesion count results were moderately correlated with GSA & GIC. Based on empirical cumulative distribution function plots of % change from BL in lesion count vs GSA change, among those who reported meaningful change, ≈30% experienced CC, ≈50% experienced at least 75% lesion reduction, & ≈70% experienced at least 50% reduction.
CONCLUSIONS: cDLQI scores improved in patients with complete & 90% MC lesion count reduction regardless of treatment arm; there were no substantial differences between 90% & CC. GSA/GIC results suggests less than CC is associated with meaningful MC change & affirmed previously published observations that lesion reduction of at least 75% are perceived as meaningful.
