Effects of Subcutaneous Hyaluronidase Administration on Psoriatic Plaques

NCT01987609 | Completed Phase 2 Results

• 1 other identifier: UCSD 131026
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Dendritic cells are a key component of the inflammatory response seen in psoriasis. Several current psoriasis therapies have been shown to reduce the number of dendritic cells in patients with psoriasis, leading researchers to believe that therapies specifically targeting dendritic cells may lead to improvement in psoriasis. Research recently conducted in Dr. Gallo's lab at the University of California San Diego has shown that transgenic mice overexpressing the enzyme hyaluronidase have a significant decrease in the number of dendritic cells in the dermal component of their skin compared to wild type mice. If hyaluronidase overexpression in humans also decreases the number of dendritic cells in the dermis, then hyaluronidase therapy may improve the clinical presentation of psoriasis. In order to test this hypothesis, recombinant human hyaluronidase (Hylenex®) will be injected subcutaneously below a psoriatic plaque in human psoriasis patients every week for a total of 4 weeks. Each week the clinical appearance of the plaque will be documented. At the final visit skin biopsies of the treated plaque will be taken to visualize the histology of the plaque and look for changes in expression of different inflammatory markers.

Conditions

Psoriasis

Keywords

Psoriasis; Dendritic cells; Hyaluronidase; Hylenex

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area Severity Index

  The Psoriasis Area Severity Index (PASI) of the psoriatic plaques of interest will be measured and compared to baseline values. The PASI is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).

  4 weeks

Secondary Outcomes (13)

• Plaque Area

  4 weeks

• Plaque Area

  2 weeks

• Plaque Area

  3 weeks

• Plaque Area

  1 weeks

• Physician Global Assessment (PGA)

  3 weeks

Other Outcomes (3)

• Adverse Events

  1 week

• Adverse Events

  2 weeks

• Adverse Events

  3 weeks

Study Arms (2)

Hylenex

EXPERIMENTAL

Psoriatic plaques in this arm will be injected with Hylenex every week for 4 weeks.

Drug: Hylenex

Normal Saline

PLACEBO COMPARATOR

Psoriatic plaques in this arm will be subcutaneously injected with sterile normal saline every week for four weeks

Drug: Normal Saline

Interventions

Hylenex DRUG

Also known as: Hylenex (R) recombinant, hyaluronidase human injection

Hylenex

Normal Saline DRUG

Also known as: Normal Saline, 0.9%

Normal Saline

Eligibility Criteria

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

You may qualify if:

• Diagnosis of plaque psoriasis for at least 6 months, with at least 2 psoriatic plaques on different parts of the body that are both between 2-cm and 5-cm in diameter at the time of screening
• Age 18-65 years
• Male subjects who agree to use barrier methods for contraception throughout the course of the trial if their female partners are of child-bearing potential, or female subjects not of child-bearing potential
• Subject agrees to comply with study requirements
• Subject is fluent in English and is able to provide written informed consent

You may not qualify if:

• Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
• Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
• Subjects who have applied topical medications (prescription or over-the-counter) for the treatment of psoriasis to their body within 7 days of the baseline visit
• Subjects who have taken cyclosporine, methotrexate, immuran, oral retinoids, chemotherapeutic agents, anti-inflammatory biologics (e.g., alefacept, etanercept, etc.), or oral calcineurin inhibitors within 28 days of the baseline visit
• Subjects who are unable to hold their current psoriasis medications for the period of time indicated (at least 7 days for topical medications, at least 28 days for oral or injectable medications) without significant worsening of their psoriasis
• Immunocompromised subjects (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or subjects with a history of malignant disease (excluding non-melanoma skin cancer) as determined by the participant's medical history.
• Subjects receiving phototherapy (e.g., ultraviolet light B \[UVB\], psoralen plus ultraviolet light A \[PUVA\]) within 28 days of the baseline visit
• Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
• Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
• Subjects who have used any systemic antibiotics within 28 days of the baseline visit
• Subjects with an active bacterial, viral or fungal skin infection (excluding nail fungus)
• Subjects currently receiving lithium or have received lithium within the last 4 weeks.
• Ongoing participation in an investigational drug trial
• Subjects with diabetes requiring medication
• Presence of psoriasis with exfoliative erythroderma or presence of guttate psoriasis, primary palmoplantar psoriasis, or pustular psoriasis

Sponsors & Collaborators

• Tissa Hata, MD: lead

Study Sites (1)

UCSD Division of Dermatology

San Diego, California, 92122, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Director of Clinical Trials Unit
• Organization: UCSD Medicine

dermstudies@Ucsd.edu

858-657-8322

Study Officials

• Tissa Hata, MD

  UCSD Division of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 19, 2013
• Study Start: July 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: February 1, 2018
• Last Updated: January 4, 2019
• Results First Posted: January 4, 2019

Record last verified: 2018-12

Locations

US (1)