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

NCT03069144 | Completed Phase 1 DMC

• 1 other identifier: HCTP2211A
• Study Type: interventional
• Target: 28
• 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 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.

Conditions

Psoriasis; Psoriasis Vulgaris

Keywords

Psoriasis; Topical

Outcome Measures

Primary Outcomes (1)

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

  [Time Frame: Baseline to week 12]

Secondary Outcomes (2)

• 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 solution

EXPERIMENTAL

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

Calcipotriol ointment (0.005%)

ACTIVE COMPARATOR

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

Interventions

HAT1 topical solution DRUG

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.

Also known as: HAT1

HAT1 topical solution

Calcipotriol DRUG

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.

Also known as: Calcipotriol 0.005%

Calcipotriol ointment (0.005%)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

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 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 3, 2017
• Study Start: January 6, 2012
• Primary Completion: April 11, 2012
• Study Completion: May 28, 2012
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share