Systemic Sclerosis (SSc)Phase 3Botox SSc-RPNCT07759557
Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon
A Phase 3 study testing Botulinum toxin A via microneedle in people with Systemic Sclerosis (SSc) and Raynaud Disease Secondary to Scleroderma, run by Khon Kaen University.
Trial summary
Raynaud's Phenomenon (RP), a vasospastic disorder causing digital ischemia and potential tissue necrosis, is effectively treated with Botulinum Toxin Type A (BTX-A) in refractory cases. However, standard administration requires painful, invasive injections that risk infection and localized muscle weakness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma
- What is being tested?
- Botulinum toxin A via microneedle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- SSc patients aged between 18 and 70 years
- Diagnosed according to ACR/EULAR 2013 classification criteria20
- Having RP with/without DU on fingers or toes
- Understand and able to read and write Thai language
- Stable steroid, immunosuppressant, and vasodilator including CCB, PDE5i for at least 4 weeks before enrollment
Who cannot join
- History of allergy or hypersensitivity to Botulinum toxin or ISDN
- Overlap with other connective tissue diseases
- Documented having peripheral arterial disease or vasculitis that affected vascular supply of fingers or toes
- Current use of 2% ISDN cream for treatment of RP
- Current use vasoconstrictor or medication that has vasoconstrictor effect such as ergotamine sulfate, beta-blocker
- Pregnancy and lactating patients
Show all 13Show fewer
- Bedridden and confined to no self-care
- Evidence of active malignant disease
- Active infection or sepsis
- Localized infection of hand
- Impaired of intrinsic muscle hand function
- Active smoker
- Prior upper extremity vascular surgery, including surgical sympathectomy within 1 month before enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon and Digital Ulcers in Systemic Sclerosis: A Randomized Placebo-Controlled Trial
Raynaud's Phenomenon (RP), a vasospastic disorder causing digital ischemia and potential tissue necrosis, is effectively treated with Botulinum Toxin Type A (BTX-A) in refractory cases. However, standard administration requires painful, invasive injections that risk infection and localized muscle weakness. To address these limitations, this randomized, placebo-controlled, parallel-group study evaluates a microneedle delivery system designed to reach the dermis while avoiding systemic circulation. By penetrating 70-80% of their height, these microneedles aim to improve hand function and symptom scores for adult systemic sclerosis patients through a more comfortable, portable, and less invasive method that increases delivery surface area while minimizing pain.
Read the detailed description
Background
Botulinum toxin-A (BTX-A) has demonstrated effectiveness in treating Raynaud's phenomenon in systemic sclerosis (RP-SSc) by improving hand function and condition scores. The current standard of care requires BTX-A to be administered via multiple, painful invasive injections, which carry recognized risks including local infection at injection sites and transient localized intrinsic hand muscle weakness due to toxin diffusion. Microneedles are developed to reduce injection pain and provide a less invasive method than conventional injections. This study evaluates the efficacy and adverse reactions of a BTX-A microneedle pad compared with 2% topical isosorbide dinitrate (ISDN) cream for the treatment of RP-SSc. The microneedles are specifically designed to penetrate the epidermis and reach the dermis layer. This design facilitates localized drug delivery while ensuring the needle tips do not reach blood vessels, preventing the drug from entering systemic circulation. The microneedle array is engineered with an evaluated penetration depth of around 70-80% of its height. The targeted insertion sites for the microneedles are located on the lateral and slightly dorsal aspects of the proximal finger base.
Study Design and Treatment Arms
The trial is a randomized, placebo-controlled, parallel-group study.
Group A (Botox) receives a one-time BTX-A microneedle pad (10 units per pad) applied once on the affected hand plus topical placebo cream applied three times daily.
Group B (Nitrate) receives a placebo microneedle pad (normal saline) applied once plus 2% topical ISDN cream applied three times daily.
Drug Preparation and Administration
The investigational BTX-A product is supplied as a sterile, vacuum-dried powder in a single-use vial containing 100 Units, which is reconstituted with 0.9% sterile, preservative-free sodium chloride to achieve a concentration of 10 units/mL. The medication is divided and administered to both lateral sides of the digits, with 5 units (0.5 mL) administered per side.
The 2% ISDN topical emulsion is compounded by mixing the crushed equivalent of 400 sublingual tablets (5 mg per tablet) with 85 g of a semisolid hydrophilic base. The ISDN preparation is divided into 10 g units and assigned a 6-month expiration date when stored at temperatures between 2 and 8°C.
Study Procedures and Follow-up Schedule
Baseline evaluations include medical history, serological tests, demographic data, vital signs, physical examinations, clinical characteristics of SSc, concomitant medications, and comorbidities. Routine laboratory assessments include complete blood count, erythrocyte sedimentation rate, c-reactive protein, renal function, liver function, urinalysis, creatine kinase, thyroid function test, chest radiography, pulmonary function test, and echocardiography.
Follow-up evaluations occur at Week 1, Week 4, and Week 12 post-treatment to monitor vital signs, physical examinations, clinical characteristics of SSc, routine laboratory assessments, concomitant medications, drug compliance, and complications such as intrinsic hand muscle weakness.
Withdrawal, Rescue Therapy, and Termination CriteriaParticipants will be withdrawn from the study if they develop active systemic infection, localized infection at microneedle pad sites, serious adverse events relating to BTX-A (such as weakened hand grip or paresthesia), severe local allergic reactions, intolerable pain from microneedle application, inability to tolerate wearing the patch until full absorption, worsening Raynaud's phenomenon, new digital ulcers, gangrene, severe headache, need for hospitalization, undergo hand surgery during the study, or self-withdraw. Participants withdrawn due to severe Raynaud's phenomenon or increased digital ulcer size will receive rescue therapy with a systemic vasodilator. Participants requiring rescue medication will continue to be followed for the full 12-week study period, and their data will be included in the Intention-to-Treat (ITT) analysis in compliance with ICH-GCP E6 (R3).
The study will be terminated if the prevalence of serious adverse events (weakened hand grip, paresthesia) in the BTX-A microneedle pad group exceeds 20% (7 cases), or if 15% of enrolled participants (6 cases) experience intolerable pain from the pad, bleeding, or local infection.
- Being tested
- Botulinum toxin A via microneedle, Control (Normal saline)
- Keywords
- systemic sclerosis, scleroderma related disorders, Infrared Thermography, Botulinum toxin A, Microneedle pad injection, Topical nitrate, Clinical Trial, vasodilator
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin A via microneedleDrug
Botulinum toxin A plus cream placebo
Control (Normal saline)Other
Normal saline via microneedles plus isosorbide dinitrate cream
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group A: Botulinum toxin A with placebo cream Receives: Drug: Botulinum toxin A via microneedle |
| Control group | Placebo comparator | Group B: Placebo botulinum A with isosorbide dinitrate cream Receives: Other: Control (Normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in distal digit temperature at 4 Weeks
The change in distal digit temperature is evaluated using an infrared thermometer from baseline to 4 weeks after treatment.
Measured: Baseline and 4 weeks after treatment
Secondary outcomes (8)
Change from baseline in Raynaud's Phenomenon pain severity score on the Visual Analogue Scale (VAS)
The change in pain severity related to Raynaud's phenomenon is assessed using the Visual Analogue Scale (VAS). The VAS ranges from a minimum value of 0 to a maximum value of 100, where 0 represents no pain and 100 represents the worst imaginable pain. Higher scores indicate a worse outcome (greater pain intensity).
Measured: Baseline to 1 week, baseline to 4 weeks, and baseline to 12 weeks after treatment
Number of participants experiencing local adverse events at the application site
The safety and tolerability of the intervention are evaluated by recording the number of participants who develop localized adverse events (including erythema, bleeding, dermatitis, local infection, or intolerable pain) at the microneedle pad application site.
Measured: 1 week, 4 weeks, and 12 weeks after treatment
Change from baseline in Raynaud's Condition Score (RCS)
The daily clinical severity and frequency of Raynaud's phenomenon attacks are evaluated using the Raynaud's Condition Score (RCS). The RCS is a self-assessment scale ranging from 0 to 10, where 0 represents no difficulty or severity and 10 represents extreme difficulty or severity. Higher numerical values indicate greater symptom severity and functional impairment.
Measured: Baseline to 1 week, baseline to 4 weeks, and baseline to 12 weeks after treatment
The progression of Raynaud's phenomenon (RP) to digital ulcer (DU)
The progression of RP to DU using numbers of DU at 1, 4 , and 12 weeks after treatment
Measured: 1, 4, and 12 weeks
The progression of Raynaud's phenomenon (RP) to digital ulcer (DU)
The progression of RP to DU using size in mm of DU at 1, 4 , and 12 weeks after treatment
Measured: 1, 4 , and 12 weeks after treatment
The progression of Raynaud's phenomenon (RP) to digital ulcers (DUs)
The net ulcer burden of digital ulcers using Digital Ulcer Clinical Assessment Score (DUCAS) from 0-68 at 1, 4 , and 12 weeks after treatment. The higher Digital Ulcer Clinical Assessment Score values reflects a higher degree of symptom intensity
Measured: 1, 4 , and 12 weeks after treatment
The clinical benefit and safety of microneedle pad
The clinical benefit and quality of life are evaluated using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire, which consists of two parts. The first part comprises five specific dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: 1 (no problems), 2 (some problems), and 3 (extreme problems). Selecting a level for each dimension generates a 5-digit health state profile (e.g., 11223). This profile ranges from a minimum value of 11111 to a maximum value of 33333, where higher numerical profiles indicate a worse outcome.
The second part features a standard 20-cm vertical Visual Analogue Scale where patients self-rate their overall health. The Visual Analogue Scale ranges from a minimum value of 0 ("the worst health you can imagine") to a maximum value of 100 ("the best health you can imagine"), where higher scores indicate a better outcome.
Measured: 1, 4, and 12 weeks after treatment
The clinical benefit and safety of microneedle pad
The clinical benefit and safety of microneedle pad by healthy assessment using Scleroderma Health Assessment Questionnaire (SHAQ) at 1, 4, and 12 weeks after treatment. The scores range from 0 to 3 for each symptom, with higher numerical values reflecting a higher degree of symptom intensity.
Measured: 1, 4, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, placebo-controlled, parallel-group study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- Srinagarind Hospital, Khon Kaen University, National Science and Technology Development Agency, Thailand
- Responsible party
- Principal investigator, Chingching Foocharoen, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759557
- Sponsor's protocol ID
- Botox for scleroderma-Raynaud
- Other IDs
- Khon Kaen University
- Acronym
- Botox SSc-RP
- Status last verified
- Aug 2026
- First submitted
- 3 May 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon and Digital Ulcers in Systemic Sclerosis: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07759557
- Acronym / sponsor ID
- Botox SSc-RP / Botox for scleroderma-Raynaud
- Keywords
- systemic sclerosis, scleroderma related disorders, Infrared Thermography, Botulinum toxin A, Microneedle pad injection, Topical nitrate, Clinical Trial, vasodilator
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- Srinagarind Hospital, Khon Kaen University, National Science and Technology Development Agency, Thailand
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Aug 2026 (actual)
- 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.
Raynaud's Phenomenon (RP), a vasospastic disorder causing digital ischemia and potential tissue necrosis, is effectively treated with Botulinum Toxin Type A (BTX-A) in refractory cases. However, standard administration requires painful, invasive injections that risk infection and localized muscle weakness. To address these limitations, this randomized, placebo-controlled, parallel-group study evaluates a microneedle delivery system designed to reach the dermis while avoiding systemic circulation. By penetrating 70-80% of their height, these microneedles aim to improve hand function and symptom scores for adult systemic sclerosis patients through a more comfortable, portable, and less invasive method that increases delivery surface area while minimizing pain.
Detailed description
Background
Botulinum toxin-A (BTX-A) has demonstrated effectiveness in treating Raynaud's phenomenon in systemic sclerosis (RP-SSc) by improving hand function and condition scores. The current standard of care requires BTX-A to be administered via multiple, painful invasive injections, which carry recognized risks including local infection at injection sites and transient localized intrinsic hand muscle weakness due to toxin diffusion. Microneedles are developed to reduce injection pain and provide a less invasive method than conventional injections. This study evaluates the efficacy and adverse reactions of a BTX-A microneedle pad compared with 2% topical isosorbide dinitrate (ISDN) cream for the treatment of RP-SSc. The microneedles are specifically designed to penetrate the epidermis and reach the dermis layer. This design facilitates localized drug delivery while ensuring the needle tips do not reach blood vessels, preventing the drug from entering systemic circulation. The microneedle array is engineered with an evaluated penetration depth of around 70-80% of its height. The targeted insertion sites for the microneedles are located on the lateral and slightly dorsal aspects of the proximal finger base.
Study Design and Treatment Arms
The trial is a randomized, placebo-controlled, parallel-group study.
Group A (Botox) receives a one-time BTX-A microneedle pad (10 units per pad) applied once on the affected hand plus topical placebo cream applied three times daily.
Group B (Nitrate) receives a placebo microneedle pad (normal saline) applied once plus 2% topical ISDN cream applied three times daily.
Drug Preparation and Administration
The investigational BTX-A product is supplied as a sterile, vacuum-dried powder in a single-use vial containing 100 Units, which is reconstituted with 0.9% sterile, preservative-free sodium chloride to achieve a concentration of 10 units/mL. The medication is divided and administered to both lateral sides of the digits, with 5 units (0.5 mL) administered per side.
The 2% ISDN topical emulsion is compounded by mixing the crushed equivalent of 400 sublingual tablets (5 mg per tablet) with 85 g of a semisolid hydrophilic base. The ISDN preparation is divided into 10 g units and assigned a 6-month expiration date when stored at temperatures between 2 and 8°C.
Study Procedures and Follow-up Schedule
Baseline evaluations include medical history, serological tests, demographic data, vital signs, physical examinations, clinical characteristics of SSc, concomitant medications, and comorbidities. Routine laboratory assessments include complete blood count, erythrocyte sedimentation rate, c-reactive protein, renal function, liver function, urinalysis, creatine kinase, thyroid function test, chest radiography, pulmonary function test, and echocardiography.
Follow-up evaluations occur at Week 1, Week 4, and Week 12 post-treatment to monitor vital signs, physical examinations, clinical characteristics of SSc, routine laboratory assessments, concomitant medications, drug compliance, and complications such as intrinsic hand muscle weakness.
Withdrawal, Rescue Therapy, and Termination CriteriaParticipants will be withdrawn from the study if they develop active systemic infection, localized infection at microneedle pad sites, serious adverse events relating to BTX-A (such as weakened hand grip or paresthesia), severe local allergic reactions, intolerable pain from microneedle application, inability to tolerate wearing the patch until full absorption, worsening Raynaud's phenomenon, new digital ulcers, gangrene, severe headache, need for hospitalization, undergo hand surgery during the study, or self-withdraw. Participants withdrawn due to severe Raynaud's phenomenon or increased digital ulcer size will receive rescue therapy with a systemic vasodilator. Participants requiring rescue medication will continue to be followed for the full 12-week study period, and their data will be included in the Intention-to-Treat (ITT) analysis in compliance with ICH-GCP E6 (R3).
The study will be terminated if the prevalence of serious adverse events (weakened hand grip, paresthesia) in the BTX-A microneedle pad group exceeds 20% (7 cases), or if 15% of enrolled participants (6 cases) experience intolerable pain from the pad, bleeding, or local infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, placebo-controlled, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Botulinum toxin A via microneedleGroup A: Botulinum toxin A with placebo cream |
| Control group | Placebo comparator | Other: Control (Normal saline)Group B: Placebo botulinum A with isosorbide dinitrate cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- SSc patients aged between 18 and 70 years
- Diagnosed according to ACR/EULAR 2013 classification criteria20
- Having RP with/without DU on fingers or toes
- Understand and able to read and write Thai language
- Stable steroid, immunosuppressant, and vasodilator including CCB, PDE5i for at least 4 weeks before enrollment
Key exclusion criteria (13 listed)
- History of allergy or hypersensitivity to Botulinum toxin or ISDN
- Overlap with other connective tissue diseases
- Documented having peripheral arterial disease or vasculitis that affected vascular supply of fingers or toes
- Current use of 2% ISDN cream for treatment of RP
- Current use vasoconstrictor or medication that has vasoconstrictor effect such as ergotamine sulfate, beta-blocker
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 |
|---|---|---|
| Botulinum toxin A via microneedleBotulinum toxin A plus cream placebo | Drug | Intervention group |
| Control (Normal saline)Normal saline via microneedles plus isosorbide dinitrate cream | Other | Control group |
Primary outcome
Change from baseline in distal digit temperature at 4 Weeks
Time frame: Baseline and 4 weeks after treatment
The change in distal digit temperature is evaluated using an infrared thermometer from baseline to 4 weeks after treatment.
8 secondary outcomes
Change from baseline in Raynaud's Phenomenon pain severity score on the Visual Analogue Scale (VAS)
Time frame: Baseline to 1 week, baseline to 4 weeks, and baseline to 12 weeks after treatment
Number of participants experiencing local adverse events at the application site
Time frame: 1 week, 4 weeks, and 12 weeks after treatment
Change from baseline in Raynaud's Condition Score (RCS)
Time frame: Baseline to 1 week, baseline to 4 weeks, and baseline to 12 weeks after treatment
The progression of Raynaud's phenomenon (RP) to digital ulcer (DU)
Time frame: 1, 4, and 12 weeks
The progression of Raynaud's phenomenon (RP) to digital ulcer (DU)
Time frame: 1, 4 , and 12 weeks after treatment
The progression of Raynaud's phenomenon (RP) to digital ulcers (DUs)
Time frame: 1, 4 , and 12 weeks after treatment
The clinical benefit and safety of microneedle pad
Time frame: 1, 4, and 12 weeks after treatment
The clinical benefit and safety of microneedle pad
Time frame: 1, 4, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin A via microneedle in people with Systemic Sclerosis (SSc) and Raynaud Disease Secondary to Scleroderma, run by Khon Kaen University.
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 13 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chingching Foocharoen, MD (66906784212, fching@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in distal digit temperature at 4 Weeks (time frame: Baseline and 4 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.