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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

Tracking Information
First Submitted Date  ICMJE February 19, 2019
First Posted Date  ICMJE February 21, 2019
Last Update Posted Date February 21, 2019
Actual Study Start Date  ICMJE February 29, 2016
Actual Primary Completion Date July 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • 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
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis
Official Title  ICMJE A Phase II Multicenter Randomized Double-blind Comparator-Controlled Trial of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • 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.
  • 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%
Study Arms  ICMJE
  • 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.
    Intervention: Drug: HAT1
  • 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.
    Intervention: Drug: Calcipotriol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2019)
174
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 5, 2016
Actual Primary Completion Date July 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03848806
Other Study ID Numbers  ICMJE HCTP15MDZ1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haus Bioceuticals
Study Sponsor  ICMJE Haus Bioceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Haus Bioceuticals
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP