Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects

Summary

Background:

Sjögren's syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sjögren's syndrome are not able to make enough saliva because their salivary glands are inflamed. The dry mouth that results can interfere with daily activities and can lead to dental cavities, mouth sores, and infections. Injections of corticosteroids into the parotid glands can improve saliva production in people with Sjögren's syndrome, but current treatment practices may provide only temporary relief. Researchers are interested in studying the effectiveness of stronger corticosteroid injections (using dexamethasone) to determine how the corticosteroid treatment actually works.

Objectives:

\- To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva production in individuals with primary Sjögren's syndrome.

Eligibility:

\- Women between 18 and greater of age who have been diagnosed with primary Sjögren's syndrome, and have had a biopsy of the minor salivary glands in the past 5 years that shows a moderate level of inflammation.

Design:

* Participants will be screened with a full medical history and physical examination, blood and urine tests, and salivary gland biopsies. Participants will also be screened with tests of saliva flow production and evaluation of the salivary ducts and glands, and will complete questionnaires about dry mouth symptoms.
* At the first treatment visit, participants will receive an injection of dexamethasone into one parotid gland and an injection of saline into the other gland. After the injections, participants will provide a blood sample to test the level of dexamethasone in the blood.
* Two weeks after the first treatment, participants will return for an evaluation visit to have saliva flow rate measurements taken, and will complete a questionnaire about dry mouth symptoms.
* Four weeks after the first treatment, participants will have a second treatment for each parotid gland, with the same tests and questionnaires as before.
* Participants will have additional evaluation visits 6 and 8 weeks after the first treatment visit, with a followup telephone call approximately 6 weeks after the last dexamethasone treatment visit.

Conditions

• Sjögren's Syndrome
• Xerostomia

Interventions

DRUG

Dexamethasone Parotid Irrigation

Irrigation of the parotid gland from one side of the mouth with dexamethasone.

DRUG

Placebo Parotid Irrigation

Irrigation of the parotid gland on the opposite side of the mouth with placebo saline.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR)

  lead NIH

Principal Investigators

• Ilias G Alevizos, D.M.D. · National Institute of Dental and Craniofacial Research (NIDCR)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-01

Primary Completion

2017-04-17

Completion

2017-04-17

FDA Drug

Yes

Countries

• United States

Study Locations