Efficacy and Tolerability of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis
Condition: Psoriasis; Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/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 further 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 study is an exploratory 10-week open-label clinical study designed to evaluate the
      efficacy and safety of HAT1 when compared to calcipotriol in adult patients with mild to
      moderate chronic plaque psoriasis. The study will include subjects with ages 18 - 65 years
      old inclusive. Group assignments will be balanced by disease severity, age, and body location
      of lesions. The study will consist of a 1 week washout period and a 12 week treatment phase.
      During the treatment phase, subject will be provided one of the two labeled test products
      HAT1 or calcipotriol to use twice daily on all lesions and non-lesional areas as instructed.
      No additional creams, lotions or soaps other than provided test products will be allowed
      throughout the duration of the study. There will also be consumption/compliance checks and
      dermatological evaluations at each visit.
    

Intervention name(s): HAT1 topical solution; Calcipotriol
Intervention type(s): Drug; Drug
Intervention description(s): HAT1 topical solution will be applied twice daily. 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.; Calcipotriol ointment (0.005%) will be applied twice daily. 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): HAT1; Calcipotriol 0.005%
Intervention MeSH terms: Calcitriol; Calcipotriene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriasis; Topical