National Institute of Health

Scientists conduct pilot trial to test the effectiveness of a novel drug that may instantly relieve itching

Skin conditions that cause chronic itching can affect one’s quality of life. Unfortunately, available topical treatments, such as menthol, do not provide lasting relief and can cause irritation. Now, scientists from Hallym University College of Medicine, Korea, have conducted a randomized controlled trial for Cryosim-1, a promising chemical with a cooling effect on the skin. Their results show that Cryosim-1 may be useful for patients with urticaria, providing near-instant and persistent itch relief.

Urticaria affects about 20% of the global population at least once in their lifetime, making it an extremely common condition that can significantly decrease one’s quality of life.

Photo Courtesy: Shutterstock

Excessive itching can quickly turn into a major problem that reduces a person’s quality of life. If left unchecked, it can lead to insomnia, negative moods, and stress. Unfortunately, although various methods have been developed for keeping itches under control, most are unable to do so immediately and instead take hours to have a noticeable effect. Thus, many dermatologists around the world are looking for new ways to combat itching.

One commonly used approach is the application of menthol or similar topical cooling agents, which presumably inhibit pain- and itch-related signaling by activating a cellular ion channel called “TRPM8.” However, the relief provided by menthol doesn’t last long, and it can sometimes cause irritation. This led to the creation of Cryosim-1, a chemical that specifically targets TRPM8 channels and, when applied as a gel, produces a quick cooling sensation that may relieve itching.

In a recent study published in the Journal of the American Academy of Dermatology, a team of scientists from Hallym University College of Medicine, Korea, put Cryosim-1 gel to the test as an anti-itching ointment. Led by Associate Professor Hye One Kim of the Department of Dermatology at Kangnam Sacred Heart Hospital, the team conducted a double-masked, randomized controlled trial consisting of two parts. The study was supported by grants from Korea Centers for Disease Control and Prevention (2020-ER6714-00).

In the first part of the study, 39 patients with recalcitrant itch were given either Cryosim-1 gel or a “vehicle-only” (or inactive) gel and asked to provide a numeric rating for their itching on a scale from 0 to 10. The overall response of patients treated with Cryosim-1 was better than those treated with the placebo, with the itch scale scores of the former decreasing significantly within the first two hours and staying relatively low after one week.

In the second part of the study, the researchers provided eczema, urticaria, and post-shingles pruritus patients with Cryosim-1 gel and used the 5-D Itch Scale to analyze how they responded to the drug. “The 5-D Itch Scale is a useful tool that assesses various components of itch, such as duration, distribution, and degree of itching, as well as how it affects quality of life through disability,” explains Dr. Kim. The results showed that Cryosim-1 was particularly effective for chronic urticaria patients, and that the drug could provide relief in as little as 10 minutes. Moreover, the anti-itching effect persisted at two hours post-administration.

Overall, this pilot trial lights a beacon of hope for those suffering from urticaria, a condition that affects as much as 20% of the population at least once in their life. “The standard treatment for urticaria is oral antihistamines, which require a minimum of one hour for the onset of its effects,” explains Dr. Kim. “Patients may prefer a topical medication that provides instant relief, within minutes if possible.” Based on the promising results of this study, Cryosim-1, as well as other TRPM8 activators, shall be further investigated as supplementary agents to treat itching and, more specifically, urticaria.

Let us hope future topical medicines for itchy skin are up to scratch!

Reference

Authors                         Min Je Jung¹, Jin Cheol Kim¹, Edward Tak Wei², Tudor Selescu³, Bo Young Chung¹, Chun Wook Park¹, and Hye One Kim¹

Title of original paper    A randomized, vehicle-controlled clinical trial of a synthetic TRPM8 agonist (Cryosim-1) gel for itch

Journal                         Journal of the American Academy of Dermatology

DOI                              10.1016/j.jaad.2020.10.065

Affiliations                     ¹Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine

                                     ²School of Public Health, University of California

                                     ³Department of Anatomy, Physiology and Biophysics, Faculty of Biology, University of Bucharest

About National Institute of Health in Korea 

The Korea National Institute of Health (KNIH), one of the major operating components of the Ministry of Health and Welfare, leads the nation’s medical research. Over the past seven decades, the KNIH has made unwavering efforts to enhance the public’s health and innovate biomedical research. The KNIH seeks to eradicate diseases and make people healthier. The KNIH establishes a scientific basis and evidence underlying health policy as well as provides national research infrastructures. We also promote public health research. To this end, we make efforts to enrich a health research environment by granting funds to research projects and keeping our resources, data, and facilities more open and accessible to researchers.

Website: http://www.nih.go.kr/eng/

About Associate Professor Hye One Kim

Hye One Kim is an Associate Professor of Dermatology and the Director of Dermatology at Kangnam Sacred Heart Hospital, Korea. Her group is developing approaches to treat the pruritus in several dermatologic diseases. They are also trying to find out an appropriate ion channel for treating pruritic diseases.