Systemic SclerosisEarly Phase 1NCT03060551

Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients

A Early Phase 1 study testing SVF injection in people with Systemic Sclerosis, run by Suk-Ho Moon at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months will suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Systemic Sclerosis
What is being tested?: SVF injection
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteSouth Korea
Study dates: 1 Jul 2018to 30 Dec 2019
Phase: Early Phase 1
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age over 18 year old
Cochin Hand Function Scale (CHFS) > 20/90

Who cannot join

new vasodilators or immunosuppressive therapy for SSc in the 3 months prior to enrolment
new vasodilators or immunosuppressive therapy for SSc during the 6-month follow-up
clinical or radiological signs of digital infection
positive status for HIV
positive status for hepatitis B or C
positive status for human T-cell leukemia virus 1-2

Show all 9Show fewer

positive status for syphilis
pregnancy
BMI less than 17kg/m2

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul

Other trials in South Korea

About this study

Official title: Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients

Read the detailed description

In patients with systemic sclerosis(scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relived by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognized as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. The investigators aimed to measure for the first time the safety, tolerability, and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability.

Conditions: Systemic Sclerosis
Being tested: SVF injection
Keywords: stromal vascular fraction, hand disability, mesenchymal stem cells, phase I trial
Medical subject headings: Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SVF injectionProcedure or surgery
SVF is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with systemic sclerosis

Study groups in NCT03060551
Study group	Role	What they receive
SVF injection	Experimental	SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles Receives: Procedure: SVF injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Raynaud's Condition Scale
The severity of Raynaud's phenomenon was assessed using the Raynaud's condition scale (ranging 0 to 10, with higher scores representing more severe Raynaud's phenomenon)
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Hand Visual Analogue Scale
Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Colchin Hand Function Scale
The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Kapandji Score (Ranging 0 to 10) - Dominant Hand
Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Kapandji Score (Non-dominant Hand)
Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
Disease-related QOL (quality of life) was measured by EuroQol-5 dimensions time trade-off (EQ-5D TTO, ranging 0 to 1, with higher values representing better QOL) values
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The Degree of Hand Edema (Right)
The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The Degree of Hand Edema (Left)
The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

Secondary outcomes (6)

Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)
In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)
In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)
In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)
In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)
In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)
In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201830 Dec 2019

First posted23 Feb 2017
Study start1 Jul 2018
Primary completion30 Dec 2019
Study completion30 Dec 2019

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 Systemic SclerosisStudies 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: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Systemic sclerosis patients with hand disability, planning 24 weeks of follow-up period Autologous adipose tissue-derived stromal vascular fraction(SVF) injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles.
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03060551
Sponsor's protocol ID: SVF treatment in SSc
Status last verified: Oct 2020
First submitted: 9 Nov 2016
Last updated: 8 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Park Y, Lee YJ, Koh JH, Lee J, Min HK, Kim MY, Kim KJ, Lee SJ, Rhie JW, Kim WU, Park SH, Moon SH, Kwok SK. Clinical Efficacy and Safety of Injection of Stromal Vascular Fraction Derived from Autologous Adipose Tissues in Systemic Sclerosis Patients with Hand Disability: A Proof-Of-Concept Trial. J Clin Med. 2020 Sep 19;9(9):3023. doi: 10.3390/jcm9093023.
PubMed 32961802

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
ClinicalTrials.gov ID: NCT03060551
Acronym / sponsor ID: SVF treatment in SSc
Conditions: Systemic Sclerosis
Keywords: stromal vascular fraction, hand disability, mesenchymal stem cells, phase I trial
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Suk-Ho MoonUniversity, hospital or other
Study start: 1 Jul 2018 (actual)
Primary completion: 30 Dec 2019 (actual)
Study completion: 30 Dec 2019 (actual)
First posted: 23 Feb 2017 (actual)
Results: Posted 8 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Systemic sclerosis patients with hand disability, planning 24 weeks of follow-up period Autologous adipose tissue-derived stromal vascular fraction(SVF) injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles.

Arm	Type	Receives
SVF injection	Experimental	Procedure: SVF injectionSVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

age over 18 year old
Cochin Hand Function Scale (CHFS) > 20/90

Key exclusion criteria (9 listed)

new vasodilators or immunosuppressive therapy for SSc in the 3 months prior to enrolment
new vasodilators or immunosuppressive therapy for SSc during the 6-month follow-up
clinical or radiological signs of digital infection
positive status for HIV
positive status for hepatitis B or C

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
SVF injectionSVF is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with systemic sclerosis	Procedure or surgery	SVF injection

Primary outcome

Raynaud's Condition Scale
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The severity of Raynaud's phenomenon was assessed using the Raynaud's condition scale (ranging 0 to 10, with higher scores representing more severe Raynaud's phenomenon)
Hand Visual Analogue Scale
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)
Colchin Hand Function Scale
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores
Kapandji Score (Ranging 0 to 10) - Dominant Hand
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Kapandji Score (Non-dominant Hand)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (quality of life) was measured by EuroQol-5 dimensions time trade-off (EQ-5D TTO, ranging 0 to 1, with higher values representing better QOL) values
Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)
Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)
The Degree of Hand Edema (Right)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema
The Degree of Hand Edema (Left)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema

6 secondary outcomes

Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

Results and safety

Results posted to the registry on 8 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SVF Injection Group	20	18

Primary outcome: Raynaud's Condition Scale

Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks. Median (Inter-Quartile Range). Unit: score on a scale

Measure	SVF Injection Group n = 18
baseline	5 (1.8 to 7.3)
2 weeks	5 (2 to 7.3)
6 weeks	6.5 (4.5 to 7.0)
12 weeks	3 (2 to 5)
24 weeks	6 (2 to 7.5)

SVF Injection Group: p = 0.256, Wilcoxon (Mann-Whitney)

Primary outcome: Hand Visual Analogue Scale

Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks. Median (Inter-Quartile Range). Unit: score on a scale

Measure	SVF Injection Group n = 18
baseline	5 (2.5 to 5)
2 weeks	4 (2 to 5)
6 weeks	5 (3.5 to 6)
12 weeks	4 (2 to 6)
24 weeks	5 (2.5 to 7)

SVF Injection Group: p = 0.682, Wilcoxon (Mann-Whitney)

Primary outcome: Colchin Hand Function Scale

Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks. Median (Inter-Quartile Range). Unit: score on a scale

Measure	SVF Injection Group n = 18
Baseline	7.5 (3.3 to 21.8)
2 weeks	14 (0 to 23.3)
6 weeks	16 (1.5 to 30.3)
12 weeks	18 (1 to 27.5)
24 weeks	17 (1.5 to 33)

SVF Injection Group: p = 0.151, Wilcoxon (Mann-Whitney)

Primary outcome: Kapandji Score (Ranging 0 to 10) - Dominant Hand

Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks. Median (Inter-Quartile Range). Unit: score on a scale

Measure	SVF Injection Group n = 18
Baseline	9 (8 to 9)
2 weeks	9 (8 to 9)
6 weeks	9 (8 to 9)
12 weeks	9 (8 to 9)
24 weeks	8 (8 to 9)

SVF Injection Group: p = 0.516, Wilcoxon (Mann-Whitney)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SVF Injection Group	0 of 20 (0%)	5 of 20 (25%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32961802Park Y, Lee YJ, Koh JH, Lee J, Min HK, Kim MY, Kim KJ, Lee SJ, Rhie JW, Kim WU, Park SH, Moon SH, Kwok SK. Clinical Efficacy and Safety of Injection of Stromal Vascular Fraction Derived from Autologous Adipose Tissues in Systemic Sclerosis Patients with Hand Disability: A Proof-Of-Concept Trial. J Clin Med. 2020 Sep 19;9(9):3023. doi: 10.3390/jcm9093023.
Individual participant dataSharing planned: No

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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.

Suk-Ho Moon, MD, PhD study director

Seoul St. Mary's Hospital

Seung-Ki Kwok principal investigator

Seoul St. Mary's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing SVF injection in people with Systemic Sclerosis, run by Suk-Ho Moon at 1 site in South Korea.

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 9 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 8 Oct 2020. 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 South Korea. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2020). 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?

Raynaud's Condition Scale (time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks). The study lists 10 primary outcomes in all. 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 NCT03060551, 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 8 Oct 2020.