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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848806
• Other study ID #: HCTP15MDZ1
• Status: Completed
• Phase: Phase 2
• Start date: February 29, 2016
• Est. completion date: September 5, 2016

Study information

• Verified date: February 2019
• Source: Haus Bioceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: September 5, 2016
• Est. primary completion date: July 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Haus Bioceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients who achieve a Psoriasis Area and Severity Index (PASI) 50 response	50% or greater reduction from baseline in the PASI score	Time Frame: Baseline to week 12
Secondary	Percentage of patients achieving a Physicians Global Assessment (PGA) of Clear or Minimal at Week 12	Reduction of PGA score from baseline to 0 (clear) or 1 (minimal disease)	Time Frame: Baseline to week 12
Secondary	Incidence of treatment emergent adverse events	Each patient were assessed for treatment emergent adverse events as part of safety assessments.	Time Frame: Baseline to week 12