KERATOCONJUNCTIVITIS SICCANCT02066896
Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome
A study testing Lasertherapy in people with KERATOCONJUNCTIVITIS SICCA and XEROSTOMIA, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- KERATOCONJUNCTIVITIS SICCA, XEROSTOMIA, SICCA SYNDROME
- What is being tested?
- Lasertherapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary Sjogren Syndrome according criteria american european 2002.
- Salivary flux non stimulated < 0,1 ml/min.
Who cannot join
- hepatitis B and/or C
- radiotherapy in the glandular area (previous)
- other connective diseases
- thyroidopathy non compensated
- GVHD graft-versus-host disease
- HIV
- Sarcoidosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Level Laser Therapy For The Treatment Of Xerostomia In Primary Sjogren's Syndrome
This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome.
Read the detailed description
The Sjogren's Syndrome is a disease that affects around 0,5% of the population and is mainly characterized for inflammatory involvement of salivary and lacrimal glands.
The xerostomia leads to low quality of life caused by dry sensations that can disturb the taste, the speaking, the swallow and chewing functions in the affected patients. The absent saliva can cause increase of dental caries and decays.
Until now, there is no effective treatment that increases the amount of saliva and the patients have low improvements with cholinergic drugs such as pilocarpine and cevimeline. These drugs can cause unpleasant collateral effects.
- Being tested
- Lasertherapy, Sham Lasertherapy
- Keywords
- Sjogrens Syndrome, Syndrome, Sjogren's, Sjogren Syndrome, Sicca Syndrome, Syndrome, Sicca
- Medical subject headings
- Keratoconjunctivitis Sicca, Xerostomia, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LasertherapyDevice
Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)
Sham LasertherapyDevice
Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).
| Study group | Role | What they receive |
|---|---|---|
| Sham Comparator: Sham Lasertherapy | Sham comparator | Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks. Receives: Device: Sham Lasertherapy |
| Active Comparator: Lasertherapy | Active comparator | Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks. Receives: Device: Lasertherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Xerostomia Inventory
The Xerostomia Inventory (XI) is an 11-item questionnaire (Thomson et al, 1999). Scores to the 11 items are summated, providing a single score (5-55) representing the subjective severity of xerostomia. In 2012, da Mata published a validated version in portuguese and we used this version. The better score is the lowest. The significant variation is defined as 6 or more.
Bellow we describe all the 11 questions:
- I sip liquids to aid in swallowing food
- My mouth feels dry when eating a meal
- I get up at night to drink
- My mouth feels dry
- I have difficulty in eating dry foods
- I suck sweets or cough lollies to relieve dry mouth
- I have difficulties swallowing certain foods
- The skin of my face feels dry
- My eyes feel dry
- My lips feel dry
- The inside of my nose feels dry __________________________________________________________
Score:
Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)
Measured: 6 weeks
Secondary outcomes (2)
Salivary Biomarker Analysis. Beta 2 Microglobulin.
The saliva in Sögren's syndrome patients has a high level of beta 2 microglobulin reflecting progression of the disease and inflammatory process at glandular epithelium.
The saliva samples were collected at the baseline and end point. Beta 2 microglobulin was determined by Elisa human kit (ABCAM ab 108885).
The normal levels are 1,2 +/- 0,7 microg/ml, and for primary Sjögren's syndrome 5,3 +/- 4,6 microg/ml.
This measure was done in the samples of saliva before and after the lasertherapy for all patients.
Measured: 6 weeks
Salivary Flux Measurement
The salivary flux was measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room. Spilled saliva was collected in a graduated Falcon 15ml tube. The samples of saliva were frozen and stored at -20° C.
Normal salivary stimulated flux is above 0,5 ml/min. Normal unstimulated salivary flux is above 0,2 ml/min.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KERATOCONJUNCTIVITIS SICCAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TANIA SALES DE ALENCAR FIDELIX, Federal University of São Paulo
- Investigators
- Virginia M Trevisani, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066896
- Sponsor's protocol ID
- LLLXS
- Status last verified
- Apr 2017
- First submitted
- 15 Aug 2013
- Last updated
- 3 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Fidelix T, Czapkowski A, Azjen S, Andriolo A, Neto PH, Trevisani V. Low-level laser therapy for xerostomia in primary Sjogren's syndrome: a randomized trial. Clin Rheumatol. 2018 Mar;37(3):729-736. doi: 10.1007/s10067-017-3898-9. Epub 2017 Nov 9.
PubMed 29119483
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Therapy For The Treatment Of Xerostomia In Primary Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT02066896
- Acronym / sponsor ID
- LLLXS
- Keywords
- Sjogrens Syndrome, Syndrome, Sjogren's, Sjogren Syndrome, Sicca Syndrome, Syndrome, Sicca
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Posted 3 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome.
Detailed description
The Sjogren's Syndrome is a disease that affects around 0,5% of the population and is mainly characterized for inflammatory involvement of salivary and lacrimal glands.
The xerostomia leads to low quality of life caused by dry sensations that can disturb the taste, the speaking, the swallow and chewing functions in the affected patients. The absent saliva can cause increase of dental caries and decays.
Until now, there is no effective treatment that increases the amount of saliva and the patients have low improvements with cholinergic drugs such as pilocarpine and cevimeline. These drugs can cause unpleasant collateral effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Comparator: Sham Lasertherapy | Sham comparator | Device: Sham LasertherapySham lasertherapy in parotid, submandibular and sublingual glands for six weeks. |
| Active Comparator: Lasertherapy | Active comparator | Device: LasertherapyLow level lasertherapy in parotid, submandibular and sublingual glands for six weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary Sjogren Syndrome according criteria american european 2002.
- Salivary flux non stimulated < 0,1 ml/min.
Key exclusion criteria (7 listed)
- hepatitis B and/or C
- radiotherapy in the glandular area (previous)
- other connective diseases
- thyroidopathy non compensated
- GVHD graft-versus-host disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LasertherapyLaser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group) | Device | Active Comparator: Lasertherapy |
| Sham LasertherapyLaser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group). | Device | Sham Comparator: Sham Lasertherapy |
Primary outcome
The Xerostomia Inventory
Time frame: 6 weeks
The Xerostomia Inventory (XI) is an 11-item questionnaire (Thomson et al, 1999). Scores to the 11 items are summated, providing a single score (5-55) representing the subjective severity of xerostomia. In 2012, da Mata published a validated version in portuguese and we used this version. The better score is the lowest. The significant variation is defined as 6 or more. Bellow we describe all the 11 questions: 1. I sip liquids to aid in swallowing food 2. My mouth feels dry when eating a meal 3. I get up at night to drink 4. My mouth feels dry 5. I have difficulty in eating dry foods 6. I suck sweets or cough lollies to relieve dry mouth 7. I have difficulties swallowing certain foods 8. The skin of my face feels dry 9. My eyes feel dry 10. My lips feel dry 11. The inside of my nose feels dry __________________________________________________________ Score: Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)
2 secondary outcomes
Salivary Biomarker Analysis. Beta 2 Microglobulin.
Time frame: 6 weeks
Salivary Flux Measurement
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29119483Fidelix T, Czapkowski A, Azjen S, Andriolo A, Neto PH, Trevisani V. Low-level laser therapy for xerostomia in primary Sjogren's syndrome: a randomized trial. Clin Rheumatol. 2018 Mar;37(3):729-736. doi: 10.1007/s10067-017-3898-9. Epub 2017 Nov 9.
- Individual participant dataSharing planned: Undecided
Related trials for KERATOCONJUNCTIVITIS SICCA
Not yet recruitingPhase 2
A Dose Regimen Study of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease
Dry Eye Disease (DED), Keratoconjunctivitis Sicca
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia M Trevisani, PhD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lasertherapy in people with KERATOCONJUNCTIVITIS SICCA and XEROSTOMIA, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Xerostomia Inventory (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02066896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.