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

NCT03848806 | Completed Phase 2 DMC

• 1 other identifier: HCTP15MDZ1
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 75 response

  75% or greater reduction from baseline in the PASI score

  Time Frame: Baseline to week 12

Secondary Outcomes (3)

• Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 50 response

  Time Frame: Baseline to week 12

• 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

Study Arms (2)

HAT1 topical

EXPERIMENTAL

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

Calcipotriol

ACTIVE COMPARATOR

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

Interventions

HAT1 DRUG

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.

HAT1 topical

Calcipotriol DRUG

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.

Also known as: Calcipotriol 0.005%

Calcipotriol

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Haus Bioceuticals: lead

MeSH Terms

Conditions

Psoriasis

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: February 29, 2016
• Primary Completion: July 11, 2016
• Study Completion: September 5, 2016
• Last Updated: February 21, 2019

Record last verified: 2019-02