Purpose (the aim of the study): Interleukin (IL)-10 is a regulator of cytokine activity and has the potential to restore homeostasis in osteoarthritis (OA) of the knee. XT-150 is a non-viral gene therapy designed to durably express a proprietary variant of the anti-inflammatory cytokine IL-10 (IL-10v). XT-150-2-0204 (NCT04124042) evaluated the safety and efficacy of single and repeat intra-articular (IA) doses of XT-150 in patients with moderate-severe knee OA. The purpose of this analysis was to evaluate the efficacy findings based on baseline demographic subgroups.

Compounded cantharidin has been used for decades to treat molluscum contagiosum but lacks rigorous clinical evidence to support its safety and efficacy. VP-102 is a shelf-stable drug–device combination product that contains topical cantharidin (0.7% weight/volume [w/v]) and is being evaluated for the treatment of molluscum. Our objective was to present pooled safety and efficacy analyses of VP-102 in the treatment of molluscum compared with vehicle. Participants aged ≥ 2 years were randomized 3:2 to topical administration of VP-102 or vehicle in two randomized, double-blind, vehicle-controlled phase III trials. Study drug was applied to all baseline and new lesions once every 21 days until clear or for a maximum of four applications. Assessors blinded to treatment counted all lesions at each study visit. All adverse events (AEs) were documented. Data were pooled for analyses. In total, 310 participants received VP-102 and 218 received vehicle. Mean age was 7.5 years (range 2–60) for VP-102 and 6.8 (2–54) for vehicle. Complete clearance of all molluscum lesions at day 84 occurred in 50% of VP-102 participants and 15.6% of vehicle recipients (p < 0.0001). Mean molluscum lesion counts decreased 76% for VP-102 and 0.3% for vehicle at day 84 (p < 0.0001). The most common AEs in the VP-102 group were application site blistering, pruritus, pain, and erythema, which were generally mild or moderate in severity. Pooled analyses showed a significantly higher percentage of participants with complete molluscum lesion clearance and larger reductions in lesion counts with VP-102 than with vehicle. AEs were anticipated because of the pharmacodynamic properties of cantharidin. ClinicalTrials.gov identifiers: NCT03377790 (first posted 19 December 2017) and NCT03377803 (first posted 19 December 2017).

Key Points Question What is the efficacy and safety of VP-102, a drug-device combination containing cantharidin, 0.7% (w/v), in individuals aged 2 years or older with molluscum contagiosum compared with vehicle? Findings In 2 identical phase 3 trials (Cantharidin Application in Molluscum Patients [CAMP-1 and CAMP-2]) with a total of 582 participants, topical application of VP-102 or vehicle every 21 days for a maximum of 4 treatments resulted in complete lesion clearance rates of 46.3% (CAMP-1) and 54.0% (CAMP-2) with VP-102 vs 18% (CAMP-1) and 13% (CAMP-2) with the vehicle. The most common adverse events were primarily mild to moderate and included application site vesicles, pain, and pruritus. Meaning The findings of these trials support the efficacy and safety of a proprietary cantharidin-based drug-device combination for treatment of molluscum contagiosum in children and adults.