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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

HAT1

Calcipotriol

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HAT1 topical

Calcipotriol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

75% or greater reduction from baseline in the PASI score

Secondary Outcome Measures

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

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

Reduction of PGA score from baseline to 0 (clear) or 1 (minimal disease)

Incidence of treatment emergent adverse events

Each patient were assessed for treatment emergent adverse events as part of safety assessments.

Full Information

NCT ID

NCT03848806

First Posted

February 19, 2019

Last Updated

February 19, 2019

Sponsor

Haus Bioceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03848806

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

February 29, 2016 (Actual)

Primary Completion Date

July 11, 2016 (Actual)

Study Completion Date

September 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Haus Bioceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HAT1 topical

Arm Type

Experimental

Arm Description

Arm Title

Calcipotriol

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

HAT1

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Calcipotriol

Other Intervention Name(s)

Calcipotriol 0.005%

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

75% or greater reduction from baseline in the PASI score

Time Frame

Time Frame: Baseline to week 12

Secondary Outcome Measure Information:

Title

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

Description

50% or greater reduction from baseline in the PASI score

Time Frame

Time Frame: Baseline to week 12

Title

Percentage of patients achieving a Physicians Global Assessment (PGA) of Clear or Minimal at Week 12

Description

Reduction of PGA score from baseline to 0 (clear) or 1 (minimal disease)

Time Frame

Time Frame: Baseline to week 12

Title

Incidence of treatment emergent adverse events

Description

Each patient were assessed for treatment emergent adverse events as part of safety assessments.

Time Frame

Time Frame: Baseline to week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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)

12. IPD Sharing Statement

Learn more about this trial

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

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