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Could a painless microneedle pad ease Raynaud's in scleroderma?

NCT ID NCT07759557

Disease control Sponsor: Khon Kaen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This Phase 3 trial is testing whether a microneedle pad delivering botulinum toxin A can improve symptoms of Raynaud's phenomenon and digital ulcers in people with systemic sclerosis. The study compares the microneedle treatment to a placebo, measuring changes in finger temperature and pain scores. The goal is to see if this less invasive method can provide relief without the pain and risks of traditional injections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum toxin A delivered via a microneedle pad
What this could lead to
If effective, this could offer a less painful, non-invasive treatment option for Raynaud's phenomenon and digital ulcers in scleroderma, improving hand function and quality of life.
What could go wrong
The trial is still in Phase 3 with a relatively small number of participants, and results may not confirm the treatment's benefit. There is also a risk of side effects or the microneedle delivery not being as effective as standard injections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. SSc patients aged between 18 and 70 years 2. Diagnosed according to ACR/EULAR 2013 classification criteria20 3. Having RP with/without DU on fingers or toes 4. Understand and able to read and write Thai language 5. Stable steroid, immunosuppressant, and vasodilator including CCB, PDE5i for at least 4 weeks before enrollment Exclusion Criteria: 1. History of allergy or hypersensitivity to Botulinum toxin or ISDN 2. Overlap with other connective tissue diseases 3. Documented having peripheral arterial disease or vasculitis that affected vascular supply of fingers or toes 4. Current use of 2% ISDN cream for treatment of RP 5. Current use vasoconstrictor or medication that has vasoconstrictor effect such as ergotamine sulfate, beta-blocker 6. Pregnancy and lactating patients 7. Bedridden and confined to no self-care 8. Evidence of active malignant disease 9. Active infection or sepsis 10. Localized infection of hand 11. Impaired of intrinsic muscle hand function 12. Active smoker 13. Prior upper extremity vascular surgery, including surgical sympathectomy within 1 month before enrollment

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Conditions

The condition(s) this trial relates to.

Raynaud disease systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Raynaud disease secondary to scleroderma Systemic sclerosis (SSC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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