About this Clinical Study

Netherton syndrome (NS) is a rare hereditary genetic skin disease characterized by scaling skin, hair anomalies, increased susceptibility to atopic eczema (a skin condition that can result in dry, red and flaky skin), elevated IgE levels, and other related symptoms. Presently, there is no cure or FDA approved treatment(s) currently available for NS.

 

Topical corticosteroids, topical calcineurin inhibitors, topical retinoids, narrowband ultraviolet B phototherapy, psoralen and ultraviolet irradiation, oral acitretin, among others are treatment options frequently used by healthcare providers with varying success.

 

Quoin Pharmaceuticals, Ltd. is developing a topical medication containing a new investigational active ingredient, combined with a proprietary polymer delivery system, for the treatment of NS. With that being said, we are pleased to inform you that Quoin is now initiating a new Phase 2 study under the guidance of FDA.

 

Study #1 – Our Comparator Trial (Active vs Vehicle)

Patients must be males or females (not pregnant or breastfeeding), 14 years or older, and in good general health with a clinical diagnosis of NS (genetic testing may also be required). Patients must have NS lesions on arms or lower legs, and be off all medications in these areas. Qualified patients will receive up to 12 weeks of treatment with the majority of patients (~66.6% of those enrolled) will receive active medication.

 

Study #2 – Our Open Label Trial

Patients must be males of females (not pregnant or breastfeeding), 14 years or older, and in good general health with a clinical diagnosis of NS (genetic testing may also be required). Patients must have NS lesions on arms or lower legs.

 

Patients will be able to continue their standard of care, including systemic therapy, for the duration of the study, but must be willing to wash out of their topical therapy, if any, in the area where the investigational treatment will be applied (i.e. your arms or legs). Qualified patients will receive up to 12 weeks of treatment with all subjects receiving the active medication.

 

Qualified participants will receive study-related examinations by a physician, genetic testing to confirm Nethertons, all study visits, and study drugs. Compensation for time and participation will also be provided. Additionally, if significant travel is necessary to reach a clinical research site, travel expenses such as airfare, meals, and lodging may be reimbursed for the patient and one accompanying parent (in the case of a child).

 

If you would like to be considered for either of these exciting study, please click the “Brief Survey” button below to see if you may pre-qualify. Based upon the information provided in the survey, if you pre-qualify for this study one of our Team Members will be contacting you to discuss potential next steps. 

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Thank-You for your interest in this potential new therapy for NS.

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