The U.S. Food and Drug Administration has recently given its approval for the topical solution known as Ycanth (cantharidin) to be used in the treatment of molluscum contagiosum (molluscum) for both adult and pediatric patients, aged 2 years and older.
Ycanth employs a single-use applicator that delivers a carefully controlled formulation of cantharidin (0.7 percent), ensuring accurate topical dosing and targeted administration.
The approval of Ycanth was based on the positive results obtained from two identical phase 3 trials named CAMP-1 and CAMP-2. Both trials demonstrated that a significant number of patients treated with VP-102 (Ycanth) achieved complete clearance of all treatable molluscum lesions, satisfying the primary end point (CAMP-1: 46 percent of participants treated with VP-102 achieved complete clearance compared to 18 percent in the vehicle group; CAMP-2: 54 versus 13 percent, respectively). The rates of complete clearance were statistically significantly higher across all body regions, including the most sensitive areas, and for patients of all ages.
However, it’s important to note that local skin reactions at the site of application were common in most Ycanth-treated participants (97 percent). These reactions included vesiculation, pruritus (itchiness), pain, discoloration, and erythema (redness). Despite this, no serious adverse reactions were reported, and only a small percentage of participants in the Ycanth group (2.3 percent) and the vehicle-treated group (0.5 percent) discontinued the treatment due to adverse reactions.
Ted White, the president, and CEO of Verrica, the pharmaceutical company behind Ycanth, emphasized that since molluscum contagiosum spreads through skin-to-skin contact and the sharing of contaminated objects, an effective topical treatment like Ycanth with precise administration is crucial in preventing further transmission. He stated that the FDA’s approval of Ycanth for patients as young as 2 years old is a significant milestone, offering an important treatment option for patients and caregivers who have been struggling with this disease.
In light of the successful clinical trial results, Verrica Pharmaceuticals has been granted the approval of Ycanth by the FDA, enabling healthcare providers to provide this treatment option to their patients suffering from molluscum contagiosum.