Back to results

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

Primary Purpose

Psoriasis, Psoriasis Vulgaris

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

HAT1 topical solution

Calcipotriol

About this trial

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HAT1 topical solution

Calcipotriol ointment (0.005%)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Incidence of treatment emergent adverse events

Full Information

NCT ID

NCT03069144

First Posted

February 27, 2017

Last Updated

February 27, 2017

Sponsor

Haus Bioceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03069144

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 6, 2012 (Actual)

Primary Completion Date

April 11, 2012 (Actual)

Study Completion Date

May 28, 2012 (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 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.

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.

6. Conditions and Keywords

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

Psoriasis, Psoriasis Vulgaris

Keywords

Psoriasis, Topical

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HAT1 topical solution

Arm Type

Experimental

Arm Description

Arm Title

Calcipotriol ointment (0.005%)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

HAT1 topical solution

Other Intervention Name(s)

HAT1

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Calcipotriol

Other Intervention Name(s)

Calcipotriol 0.005%

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

[Time Frame: Baseline to week 12]

Secondary Outcome Measure Information:

Title

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

Time Frame

[Time Frame: Baseline to week 12]

Title

Incidence of treatment emergent adverse events

Time Frame

[Time Frame: baseline to week 12]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs