Efficacy and Safety of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): HAT1; Calcipotriol
Intervention type(s): Drug; Drug
Intervention description(s): During the treatment phase, patients will be ask to apply the product twice daily on all lesional areas. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study.; During the treatment phase, patients will be ask to apply the product twice daily on all lesional areas. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study.
Other intervention name(s): Calcipotriol 0.005%
Intervention MeSH terms: Calcitriol; Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis