Autoimmune ThyroiditisPhase 2NCT01129492
Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis
A Phase 2 study testing Low-level Laser therapy in people with Autoimmune Thyroiditis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate whether low-level Laser therapy is effective in ameliorating the thyroid function of patients with hypothyroidism caused by chronic autoimmune thyroiditis. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Autoimmune Thyroiditis
- What is being tested?
- Low-level Laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2006to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients previously diagnosed with hypothyroidism induced by chronic autoimmune thyroiditis (CAT). The presence of hypothyroidism, laboratory measurements and ultrasonography criteria were applied to diagnose CAT.
- Significantly elevated concentrations of thyroid peroxidase (TPOAb) and/or thyroglobulin (TgAb) autoantibodies
- Ultrasonography results consistent with CAT
- Patients undergoing LT4 treatment
- Normal (or almost normal) levels of triiodothyronine (T3), thyroxine (T4), free T4 and thyrotropin (TSH)
Who cannot join
- Use of immunosuppressants, immunostimulants, or other drugs that could interfere with the production, metabolism and transport of thyroid hormones
- CAT with normal thyroid function
- CAT with subclinical hypothyroidism
- Thyroid nodules
- Hypothyroidism stemming from post-partum thyroiditis (up to 18 months after gestation)
- History of Graves' disease
Show all 15Show fewer
- Thyrotropin receptor antibody (TRAb) detectable
- Prior treatment with radioiodine
- Tracheal stenosis
- Pregnancy
- History of ionizing irradiation and/or neoplasia in the cervical area
- Previous surgical intervention in the thyroid
- Thyroid hypoplasia
- Ectopic thyroid
- Serious illness (cancer, ischemic coronary artery disease, stroke, kidney or liver failure, etc.)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo General Hospital
São Paulo, São Paulo, 05403-001
About this study
Official title: Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis: Randomized, Placebo Controlled Clinical Trial
The purpose of this study is to evaluate whether low-level Laser therapy is effective in ameliorating the thyroid function of patients with hypothyroidism caused by chronic autoimmune thyroiditis.
Read the detailed description
Chronic autoimmune thyroiditis (CAT) is the most common cause of hypothyroidism in iodine-replete areas. An autoimmune dysfunction causes humoral and cellular responses that lead progressively to thyroiditis. There is no effective therapy available that can change the natural history of CAT, which presents a high incidence of hypothyroidism and requires continuous treatment with levothyroxine (LT4).
Laser light can be valuable since the local and systemic actions of low-level laser therapy (LLLT) have been shown to be effective in treating autoimmune diseases, such as rheumatoid arthritis and Sjogren's syndrome. There is also evidence suggesting that LLLT can facilitate regeneration of various tissues and, in animal thyroids, can lead to improvement in microcirculation and increases in serum triiodothyronine (T3) and thyroxine (T4) levels. Since the LLLT is a non-invasive, cost-effective and painless procedure, the objective of this randomized clinical trial was to evaluate the effectiveness of LLLT in patients with hypothyroidism caused by chronic autoimmune thyroiditis, based on patients' thyroid function, their concentration of thyroid autoantibodies, and the parameters of their ultrasonography study.
- Conditions
- Autoimmune Thyroiditis
- Being tested
- Low-level Laser therapy
- Keywords
- Autoimmune Thyroiditis, Laser, Therapy, Thyroid, Ultrasound
- Medical subject headings
- Thyroiditis, Autoimmune, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level Laser therapyDevice
Also called Low intensity Laser therapy, Low power Laser therapy
A continuous wave (CW) diode laser device (830nm, infrared) with a beam area of 0.2827cm2 and using the punctual method, continuous emission mode, output power of de 50mW and fluence of 70J/cm2 (40 seconds at the point of application).
| Study group | Role | What they receive |
|---|---|---|
| Sham Laser | Placebo comparator | Ten applications of placebo were performed (twice a week) with the same method and Laser equipment, which has a placebo function available with a red ordinary light indistinguishable of the Laser light. Receives: Device: Low-level Laser therapy |
| Active Laser | Active comparator | Ten applications of low-level Laser therapy (twice a week) were performed with a continuous wave diode laser device (830nm, beam area of 0.2827cm2), using the punctual method, continuous emission mode, output power of de 50 mW and fluence of 70J/cm2. Receives: Device: Low-level Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome measure was to gauge the effectiveness of applying LLLT in patients with hypothyroidism caused by CAT evaluated by a significant reduction of the levothyroxine (LT4) mean dose (µ/day) 9 months post-LT4 withdrawal.
All patients enrolled in the study were undergoing LT4 treatment. They received 10 applications of LLLT or placebo. Thirty days after intervention, LT4 was discontinued in all patients and, if required, reintroduced. T3, T4, free T4 and TSH levels (all laboratory personnel was blinded), were assessed pre-LLLT and then 1, 2, 3, 6 and 9 months post-LT4 withdrawal. The LT4 mean dose pre-LLLT and 9 months post-LT4 withdrawal was compared both in face of normal levels of T3, T4, free T4 and TSH to evaluate LLLT effectiveness.
Measured: LT4 dose, concentrations of T3, T4, free T4 and TSH were evaluated and compared before intervention and 9 months post-LT4 withdrawal.
Secondary outcomes (2)
Evaluate the LLLT efficacy in reducing thyroid autoantibodies concentrations.
Thyroid peroxidase (TPOAb) and thyroglobulin (TgAb) autoantibodies were both determined prior to LLLT and in the 1st, 2nd, 3rd, 6th and 9th months after LT4 withdrawal. All laboratory personnel was blinded to treatment assignment throughout the study.
Measured: Thyroid autoantibodies were determined and compared pre-intervention and 9 months post-LT4 withdrawal.
Evaluate the LLLT efficacy by quantitative and qualitative ultrasonography parameters.
B-mode sonography (volume, texture and echogenicity using computerized histogram) as well as power Doppler (vascularization) and pulsed Doppler (maximal systolic peak velocity and resistance index for the thyroid arteries) were performed and compared pre- and 30 days post-intervention by only one experienced and blind investigator, during the use of the same doses of LT4.
Measured: The ultrasonography parameters observed pre-LLLT were compared with those observed 30 days post-LLLT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startMar 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune ThyroiditisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Danilo B Höfling, Dr., Principal investigator, University of São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129492
- Sponsor's protocol ID
- CAPPesq 375/05
- Status last verified
- Apr 2009
- First submitted
- 14 May 2010
- Last updated
- 24 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hofling DB, Chavantes MC, Acencio MM, Cerri GG, Marui S, Yoshimura EM, Chammas MC. Effects of low-level laser therapy on the serum TGF-beta1 concentrations in individuals with autoimmune thyroiditis. Photomed Laser Surg. 2014 Aug;32(8):444-9. doi: 10.1089/pho.2014.3716.
PubMed 25101534
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis: Randomized, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01129492
- Acronym / sponsor ID
- CAPPesq 375/05
- Conditions
- Autoimmune Thyroiditis
- Keywords
- Autoimmune Thyroiditis, Laser, Therapy, Thyroid, Ultrasound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Mar 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether low-level Laser therapy is effective in ameliorating the thyroid function of patients with hypothyroidism caused by chronic autoimmune thyroiditis.
Detailed description
Chronic autoimmune thyroiditis (CAT) is the most common cause of hypothyroidism in iodine-replete areas. An autoimmune dysfunction causes humoral and cellular responses that lead progressively to thyroiditis. There is no effective therapy available that can change the natural history of CAT, which presents a high incidence of hypothyroidism and requires continuous treatment with levothyroxine (LT4).
Laser light can be valuable since the local and systemic actions of low-level laser therapy (LLLT) have been shown to be effective in treating autoimmune diseases, such as rheumatoid arthritis and Sjogren's syndrome. There is also evidence suggesting that LLLT can facilitate regeneration of various tissues and, in animal thyroids, can lead to improvement in microcirculation and increases in serum triiodothyronine (T3) and thyroxine (T4) levels. Since the LLLT is a non-invasive, cost-effective and painless procedure, the objective of this randomized clinical trial was to evaluate the effectiveness of LLLT in patients with hypothyroidism caused by chronic autoimmune thyroiditis, based on patients' thyroid function, their concentration of thyroid autoantibodies, and the parameters of their ultrasonography study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Laser | Placebo comparator | Device: Low-level Laser therapyTen applications of placebo were performed (twice a week) with the same method and Laser equipment, which has a placebo function available with a red ordinary light indistinguishable of the Laser light. |
| Active Laser | Active comparator | Device: Low-level Laser therapyTen applications of low-level Laser therapy (twice a week) were performed with a continuous wave diode laser device (830nm, beam area of 0.2827cm2), using the punctual method, continuous emission mode, output power of de 50 mW and fluence of 70J/cm2. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients previously diagnosed with hypothyroidism induced by chronic autoimmune thyroiditis (CAT). The presence of hypothyroidism, laboratory measurements and ultrasonography criteria were applied to diagnose CAT.
- Significantly elevated concentrations of thyroid peroxidase (TPOAb) and/or thyroglobulin (TgAb) autoantibodies
- Ultrasonography results consistent with CAT
- Patients undergoing LT4 treatment
- Normal (or almost normal) levels of triiodothyronine (T3), thyroxine (T4), free T4 and thyrotropin (TSH)
Key exclusion criteria (15 listed)
- Use of immunosuppressants, immunostimulants, or other drugs that could interfere with the production, metabolism and transport of thyroid hormones
- CAT with normal thyroid function
- CAT with subclinical hypothyroidism
- Thyroid nodules
- Hypothyroidism stemming from post-partum thyroiditis (up to 18 months after gestation)
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 |
|---|---|---|
| Low-level Laser therapyAlso: Low intensity Laser therapy, Low power Laser therapyA continuous wave (CW) diode laser device (830nm, infrared) with a beam area of 0.2827cm2 and using the punctual method, continuous emission mode, output power of de 50mW and fluence of 70J/cm2 (40 seconds at the point of application). | Device | Active Laser, Sham Laser |
Primary outcome
The main outcome measure was to gauge the effectiveness of applying LLLT in patients with hypothyroidism caused by CAT evaluated by a significant reduction of the levothyroxine (LT4) mean dose (µ/day) 9 months post-LT4 withdrawal.
Time frame: LT4 dose, concentrations of T3, T4, free T4 and TSH were evaluated and compared before intervention and 9 months post-LT4 withdrawal.
All patients enrolled in the study were undergoing LT4 treatment. They received 10 applications of LLLT or placebo. Thirty days after intervention, LT4 was discontinued in all patients and, if required, reintroduced. T3, T4, free T4 and TSH levels (all laboratory personnel was blinded), were assessed pre-LLLT and then 1, 2, 3, 6 and 9 months post-LT4 withdrawal. The LT4 mean dose pre-LLLT and 9 months post-LT4 withdrawal was compared both in face of normal levels of T3, T4, free T4 and TSH to evaluate LLLT effectiveness.
2 secondary outcomes
Evaluate the LLLT efficacy in reducing thyroid autoantibodies concentrations.
Time frame: Thyroid autoantibodies were determined and compared pre-intervention and 9 months post-LT4 withdrawal.
Evaluate the LLLT efficacy by quantitative and qualitative ultrasonography parameters.
Time frame: The ultrasonography parameters observed pre-LLLT were compared with those observed 30 days post-LLLT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2010.
- Derived from this study: PubMed 25101534Hofling DB, Chavantes MC, Acencio MM, Cerri GG, Marui S, Yoshimura EM, Chammas MC. Effects of low-level laser therapy on the serum TGF-beta1 concentrations in individuals with autoimmune thyroiditis. Photomed Laser Surg. 2014 Aug;32(8):444-9. doi: 10.1089/pho.2014.3716.
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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.
Danilo B Höfling, Dr. principal investigator
University of São Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-level Laser therapy in people with Autoimmune Thyroiditis, run by University of Sao Paulo General Hospital 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 5 inclusion and 15 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 24 May 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 main outcome measure was to gauge the effectiveness of applying LLLT in patients with hypothyroidism caused by CAT evaluated by a significant reduction of the levothyroxine (LT4) mean dose (µ/day) 9 months post-LT4 withdrawal. (time frame: LT4 dose, concentrations of T3, T4, free T4 and TSH were evaluated and compared before intervention and 9 months post-LT4 withdrawal.). 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 NCT01129492, 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 24 May 2010; AzTrials last refreshed its copy on 28 Oct 2026.