Effects of Subcutaneous Hyaluronidase Administration on Psoriatic Plaques

Completed · Phase 2

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID: NCT01987609
Run by: Tissa Hata, MD
People needed: 7
Starts: 2015-07-01
Expected to finish: 2018-02-01
Last updated by the study team: 2019-01-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
Hypersensitivity to hyaluronidase or any other ingredient in the formulation of hyaluronidase, as well as subjects with an allergy or hypersensitivity to lidocaine
Subjects taking furosemide, benzodiazepines, phenytoin, salicylates, cortisone, antihistamines or estrogens

Where it is running

UCSD Division of Dermatology — San Diego, California, United States

Full record on ClinicalTrials.gov

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