Cryosim-1 Safe, Effective in Patients With Prurigo Nodularis

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A recent clinical trial exploring the safety and efficacy of topical cryosim-1, a synthetic transient receptor potential melastatin 8 (TRPM8) agonist, found that cryosim-1 was both safe and effective in patients with prurigo nodularis.

The study, published in the Journal of Cosmetic Dermatology, sought to investigate the safety and efficacy of a topical TRPM8 agonist in this indication. Researchers Choi et al noted that while several topical and systemic therapeutic options have been researched for prurigo nodularis, none have yet been approved by the US Food and Drug Administration.

Prior studies, Choi et al wrote, have explored and proven the efficacy of cryosim-1 in conditions such as eczema, urticaria, and localized scalp pruritus, and therefore it may have the capability to block itching sensations associated with prurigo nodularis.

Adult patients (n=30) aged 20 years and older were enrolled in the randomized, double-blinded, placebo-controlled clinical trial between July 2022 and November 2022. In addition to the age requirement set by researchers, participants were required to have received a prurigo nodularis diagnosis as recent as 3 months prior to study initiation, at least 10 pruritic nodules present, and nodules located in at least 2 regions.

Upon enrollment, patients were randomly assigned to receive cryosim-1 or a topical placebo serum. For a duration of 8 weeks, the assigned topicals were applied to pruritic lesions 3 times per day. All patients completed a corresponding questionnaire and partook in a daily diary to log their pruritic symptoms.

A series of 3 visits were conducted with each participant, taking place at days 1, 28, and 56, approximately. Researchers measured several parameters at each visit, including transepidermal water loss (TEWL), a physical examination, evaluation of adverse reactions, and the numerical rating scale (NRS).

The pruritus NRS scores were similar between the treatment and placebo groups at baseline and week 4, but at week 8, the treatment group showed a significant reduction in pruritus scores before and after application compared to the placebo group.

Sleep disorder NRS scores decreased in both groups at week 4, with no significant difference, but at week 8, the treatment group exhibited a significant improvement compared to the placebo group.

The study also found no significant differences between the treatment and placebo groups at baseline, week 4, and week 8 regarding TEWL.

Satisfaction with the treatment's properties showed no significant differences except for pruritus improvement, where the treatment group reported higher satisfaction scores than the placebo group.

Both the treatment and placebo were well tolerated with no observed adverse reactions.

Potential study limitations included the study's 8-week treatment duration, an inability to compare the efficacy of topical cryosim-1 with other topical agents, and the inability to measure the efficacy of cryosim-1 alone, due to the researchers' allowance of use of 2 antihistamines and low-potency topical steroids.

"This randomized, double-blinded, placebo-controlled clinical trial showed that cryosim-1 could be a safe and effective treatment for reducing pruritus and improving sleep quality for [prurigo nodularis] patients," study authors wrote. "This study design reflected the real-world practice of treating [prurigo nodularis], which is commonly treated with multiple agents, oral antihistamines, and low-potency steroids, which together are not usually associated with severe side effects."

Reference

Choi ME, Lee JH, Jung CJ, et al. A randomized, double‐blinded, vehicle‐controlled clinical trial of topical cryosim‐1, a synthetic trpm8 agonist, in prurigo nodularis. J Cosmet Dermatol. Published online January 2, 2024. doi:10.1111/jocd.16079