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

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ClinicalTrials.gov Identifier: NCT03848806
Recruitment Status : Completed
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Haus Bioceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: HAT1 Drug: Calcipotriol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Randomized Double-blind Comparator-Controlled Trial of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis
Actual Study Start Date : February 29, 2016
Actual Primary Completion Date : July 11, 2016
Actual Study Completion Date : September 5, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: HAT1 topical
HAT1 topical cream will come in a blinded bottle. Patients, investigators, and the trial sponsor will be unaware of the trial group assignments. Packaging and labeling of the test and comparator products will be identical to maintain the blind.
Drug: HAT1
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.

Active Comparator: Calcipotriol
Calcipotriol topical cream will come in a blinded bottle. Patients, investigators, and the trial sponsor will be unaware of the trial group assignments. Packaging and labeling of the test and comparator products will be identical to maintain the blind.
Drug: Calcipotriol
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 Name: Calcipotriol 0.005%




Primary Outcome Measures :
  1. Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 75 response [ Time Frame: Time Frame: Baseline to week 12 ]
    75% or greater reduction from baseline in the PASI score


Secondary Outcome Measures :
  1. Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 50 response [ Time Frame: Time Frame: Baseline to week 12 ]
    50% or greater reduction from baseline in the PASI score

  2. Percentage of patients achieving a Physicians Global Assessment (PGA) of Clear or Minimal at Week 12 [ Time Frame: Time Frame: Baseline to week 12 ]
    Reduction of PGA score from baseline to 0 (clear) or 1 (minimal disease)

  3. Incidence of treatment emergent adverse events [ Time Frame: Time Frame: Baseline to week 12 ]
    Each patient were assessed for treatment emergent adverse events as part of safety assessments.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of active plaque psoriasis with a minimum PGA score of 2 but not greater than 4
  • Males or Females between 12-60 years
  • Treatment area amenable to topical treatment
  • Attending a hospital outpatient clinic or the private practice of a dermatologist
  • Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is carried out, including activities relating to washout period.

Exclusion Criteria:

  • Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis or a drug induced form of psoriasis.
  • Systemic treatment with immunosuppressive drugs or corticosteroids within 4 weeks prior to enrollment. (Inhaled or intranasal steroids for asthma or rhinitis may be used)
  • Topical treatment with immunomodulators or corticosteroids within 4 weeks prior to enrollment.
  • Phototherapy treatment within 4 weeks prior to enrollment.
  • Other topical therapy on the treatment area within 1 week prior to enrollment.
  • Use of anti-histamine treatment during the study
  • Clinical infection on the treatment area.
  • Patients with history of cancer including skin cancer.
  • Patients with history of an immunocompromised disease.
  • Current participation in any other interventional clinical trial.
  • Pregnancy or risk of pregnancy, and/or lactation
  • History of allergy of any herbal components in HAT1
  • Subjects with intense sun exposure during the study
  • Patients known or suspected of not being able to comply with a trial protocol (e.g. alcoholism, drug dependency, or psychotic state)

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Responsible Party: Haus Bioceuticals
ClinicalTrials.gov Identifier: NCT03848806     History of Changes
Other Study ID Numbers: HCTP15MDZ1
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haus Bioceuticals:
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcipotriene
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents