Maeda-Chubachi T, McLeod L, Enloe C, Cartwright M, Siegfried E, Hebert AA, Silverberg N. Defining clinically meaningful improvement in molluscum contagiosum. J Am Acad Dermatol. 2024 Feb;90(2):443-5. doi: 10.1016/j.jaad.2023.10.033

BACKGROUND: Health-related quality of life evaluations are scarce in patients with molluscum contagiosum (MC).

OBJECTIVE: To understand perceptions of MC severity and meaningfulness of MC lesion count reduction.

METHODS: Children’s Dermatology Life Quality Index (CDLQI) questionnaires were collected from B SIMPLE1 and B-SIMPLE2 patients 4—15 years (n=533). MC severity and meaningful change were evaluated in B¬ SIMPLE4 (N=891) using subject/investigator Global Severity Assessment (sGSA/iGSA) and Global Impression of Change (sGIC/iGIC) scores. Empirical cumulative distribution function analyses evaluated clinical meaningfulness of change.

RESULTS: Baseline mean (SD) composite scores of CDLQI were: 3.6 (4.5) for B-SIMPLE1 and 3.5 (4.1) for B-SIMPLE2. CDLQI scores were low at baseline and insensitive to lesion count changes. Boxplot analyses demonstrated suggest that patients/caregivers and investigators perceived MC severity by lesion count as follows: mild (<10 lesions), moderate (patients, 10-30; investigators, 10-40), severe (patients, >30; investigators, >40). Results Analyses of lesion count percent change from baseline versus changes in sGSA/iGSA and sGIC/iGIC indicated suggest a 50% lesion reduction from baseline as a plausible threshold for was clinically meaningful improvement.

LIMITATIONS: MC lesion size and locations or adverse events were not factored in the assessment.

CONCLUSIONS: MC has a small impact on CDLQI. A 50% MC lesion count reduction from baseline was is a plausible threshold for clinically meaningful improvementto patients/caregivers and investigators.

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