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

Efficacy and Safety of HAT1, a Novel Topical Therapeutic: An Open Label Pilot Study of HAT1 Compared to Calcipotriol in Patients With 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 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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Psoriasis Vulgaris
• Intervention / Treatment: Drug: HAT1 topical solution; Drug: Calcipotriol

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of psoriasis with a psoriasis area and severity index (PASI) score > 3 and < 12
• Treatment area amenable to topical treatment
• Attending a hospital outpatient clinic or the private practice of a dermatologist
• Males or Females between 18-65 years

Exclusion Criteria:

• 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 therapy within 4 weeks prior to enrollment or other topical therapy on the treatment area within 1 week prior to enrollment.
• Patients requiring any other topical or systemic medications that could affect the course of psoriasis during the study period.
• Clinical infection on the treatment area or patients with history of cancer including skin cancer, history of an immunocompromised disease.
• Current participation in any other interventional clinical trial
• History of allergy of any components in HAT1 or previously treated with 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)
• Patients that are currently pregnant or lactating or planning to become pregnant in the next 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HAT1 topical solution; HAT1 topical solution will come in a labeled spray bottle. This topical medicated solution will be applied once in the morning and once in the evening at least 8 hours apart to all lesions. Treatment will continue daily until next visit.	Drug: HAT1 topical solution; 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.; Other Names: HAT1
Active Comparator: Calcipotriol ointment (0.005%); Calcipotriol ointment (0.005%) will come in a labeled tube. The medicated cream will be be applied once in the morning and once in the evening at least 8 hours apart to all lesions. Treatment will continue daily until next visit.	Drug: Calcipotriol; 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 Names: Calcipotriol 0.005%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 75 response	[Time Frame: Baseline to week 12]

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients achieving a Physicians Global Assessment (PGA) of Clear or Minimal at Week 12	[Time Frame: Baseline to week 12]
Incidence of treatment emergent adverse events	[Time Frame: baseline to week 12]

Collaborators and Investigators

• Sponsor: Haus Bioceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2012
• Primary Completion (Actual): April 11, 2012
• Study Completion (Actual): May 28, 2012

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Psoriasis; Topical
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Calcipotriene; Calcitriol
• Other Study ID Numbers: HCTP2211A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No