Efficacy and Safety of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis

Psoriasis, the most prevalent autoimmune disease in the U.S., manifests with plaque type psoriasis vulgaris with lesions localized to the scalp, postauricular region, face, diaper area, elbows, and knees. Inadequately controlled disease is common and a significant cause of extensive psychological and clinical morbidity in children. In addition, the safety and tolerability issues of common treatments for psoriasis including topical corticosteroids, calcipotriol, oral cytotoxic drugs, and biologic agents are especially problematic in patients that limit their use. Identification of therapies with high efficacy and safety profiles suitable for patients with psoriasis is therefore an area of critical unmet need. Haus Bioceuticals has developed a topical treatment for psoriasis denoted HAT1 (based on ingredients that have established clinical benefit), and have demonstrated that HAT1 is safe and profoundly effective in the treatment of psoriasis. This study is aimed to further evaluate the efficacy and safety of HAT1 compared to commonly used calcipotriol in patients with mild to moderate chronic plaque psoriasis.

This is a randomized, double-blind trial. All patients who meet entry criteria will be randomized to receive either topical HAT01 or calcipotriol to be applied to the affected area 2 times per day. Treatment will continue for a maximum of 12 weeks. During all study visits, patients will be evaluated for efficacy and safety. The study will comprise of a 1 week washout period. During the washout period, patients will be asked to avoid using any products on their body including topical corticosteroids, ointments, creams, etc. During the treatment phase, patients will be provided one of the two test products to use twice daily on all lesional areas. No additional ointments or creams will be allowed throughout the duration of the study. Measurements and assessments will be taken according to the schedule. Patients will be followed through 12 weeks till the end of treatment.