Trial · NCT02165111

Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome

NCT02165111, Phase 3, Completed, Johns Hopkins University; results first posted 2016-12-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome. Trials, record NCT02165111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02165111

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome
NCT number: NCT02165111
Status: Completed
Phases: Phase 3
Enrollment: 40 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Scleroderma, Raynaud's Syndrome
Interventions: Onabotulinumtoxin A, sterile saline solution
First posted: 2014-06-17
Last updated: 2016-12-22
Results first posted: 2016-12-22
Limitations and caveats: Multi-level data prevents conclusions from being drawn from aggregate data alone. High degree of variability of the results suggests a heterogeneous group of scleroderma patients. Screening methods and no dose escalation may explain negative findings

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Digital Blood Flow From Pre- to Post-injection.	Measured pre-injection and at one month post-injection.	The primary outcome measure is change in blood flow to the fingers, from a pre-injection baseline to post-injection follow-up visit as measured by non-invasive laser Doppler imaging.
Secondary	Rate of Change in Raynaud's Phenomenon Symptoms Measured With the Raynaud's Condition Score.	Weekly rate of change over the four-month study period.	Raynaud's Condition Score is a patient-reported, validated outcomes scale that measures the severity of Raynaud's phenomenon on a scale of 0 ("No difficulty") to 10 ("Extreme difficulty"), where higher values represent a worse outcome. Data from each weekly report were combined using a statistical model (generalized linear population-average model) to calculate a weekly rate of change for each participant's hand, where a negative value represents a improvement over time and a positive value represents worsening over time.
Secondary	Number of Ulcers as Measure of Digital Ulcer Healing	Measured at one month post-injection.	A secondary outcome of this study is the number of digital ulcers as determined by clinical examination. Mean number of ulcers was calculated as total number of ulcers / total number of hands in each group.
Secondary	Assessment of Raynaud's Symptoms Severity Using the Quick-DASH Score.	Measured at one month post-injection.	A secondary outcome of this study is severity of Raynaud's symptoms as measured by the self-reported Quick-DASH score. The Quick-DASH scores measures the degree of hand and upper extremity function on a scale of 0 (not limited) to 100 (severely limited) where a higher value represents a worse outcome.
Secondary	Assessment of Raynaud's Symptom Severity Using the McCabe Cold Sensitivity Score.	Measured at one month post-injection.	A secondary outcome of this study is the patient-reported sensitivity to coldness as measured by the McCabe Cold Sensitivity score. Patients' answers on this validated instrument are scored on a scale from 0 (no sensitivity) to 400 (extreme sensitivity), where a higher number represents a worse outcome.
Secondary	Assessment of Raynaud's Symptom Severity Using the VAS for Pain.	Measured at one month post-injection.	A secondary outcome of this study is pain as measured by the validated visual-analog scale (VAS) for pain. The VAS pain instrument measures pain on a scale from 0 cm (no pain) to 10 cm (extreme pain)

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Digital Blood Flow From Pre- to Post-injection.	Measured pre-injection and at one month post-injection.	Blood flow, measured in LDI flux units,	MEAN
SECONDARY	Rate of Change in Raynaud's Phenomenon Symptoms Measured With the Raynaud's Condition Score.	Weekly rate of change over the four-month study period.	change in RCS/week	MEAN
SECONDARY	Number of Ulcers as Measure of Digital Ulcer Healing	Measured at one month post-injection.	Number of ulcers	MEAN
SECONDARY	Assessment of Raynaud's Symptoms Severity Using the Quick-DASH Score.	Measured at one month post-injection.	Units on a scale	MEAN
SECONDARY	Assessment of Raynaud's Symptom Severity Using the McCabe Cold Sensitivity Score.	Measured at one month post-injection.	Units on a scale	MEAN
SECONDARY	Assessment of Raynaud's Symptom Severity Using the VAS for Pain.	Measured at one month post-injection.	centimeters measured on a visual scale	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Digital Blood Flow From Pre- to Post-injection.	Onabotulinumtoxin A	-36.19	95% Confidence Interval -78.49 to 6.12	Blood flow, measured in LDI flux units,
Change in Digital Blood Flow From Pre- to Post-injection.	Placebo	-6.10	95% Confidence Interval -46.28 to 34.07	Blood flow, measured in LDI flux units,
Rate of Change in Raynaud's Phenomenon Symptoms Measured With the Raynaud's Condition Score.	Onabotulinumtoxin A	-0.18	95% Confidence Interval -0.22 to -0.13	change in RCS/week
Rate of Change in Raynaud's Phenomenon Symptoms Measured With the Raynaud's Condition Score.	Placebo	-0.14	95% Confidence Interval -0.18 to -0.11	change in RCS/week
Number of Ulcers as Measure of Digital Ulcer Healing	Onabotulinumtoxin A	0.45	Standard Deviation 0.90	Number of ulcers
Number of Ulcers as Measure of Digital Ulcer Healing	Placebo	0.53	Standard Deviation 0.93	Number of ulcers
Assessment of Raynaud's Symptoms Severity Using the Quick-DASH Score.	Onabotulinumtoxin A	26.96	Standard Deviation 20.68	Units on a scale
Assessment of Raynaud's Symptoms Severity Using the Quick-DASH Score.	Placebo	29.11	Standard Deviation 23.80	Units on a scale
Assessment of Raynaud's Symptom Severity Using the McCabe Cold Sensitivity Score.	Onabotulinumtoxin A	185.31	Standard Deviation 74.19	Units on a scale
Assessment of Raynaud's Symptom Severity Using the McCabe Cold Sensitivity Score.	Placebo	187.19	Standard Deviation 86.76	Units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	Onabotulinumtoxin A	40	40
Overall Study	STARTED	Placebo	40	40
Overall Study	COMPLETED	Onabotulinumtoxin A	40	40
Overall Study	COMPLETED	Placebo	40	40
Overall Study	NOT COMPLETED	Onabotulinumtoxin A	0	0
Overall Study	NOT COMPLETED	Placebo	0	0

Source ClinicalTrials.gov

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Intrinsic muscle weakness	Injury, poisoning and procedural complications	Onabotulinumtoxin A	2	40	2
other	Intrinsic muscle weakness	Injury, poisoning and procedural complications	Placebo	0	40	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Onabotulinumtoxin A
Total, all-cause mortality	Placebo
Total, other adverse events	Onabotulinumtoxin A	2	40
Total, other adverse events	Placebo	0	40
Total, serious adverse events	Onabotulinumtoxin A	0	40
Total, serious adverse events	Placebo	0	40

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21868066	BACKGROUND	PubMed
28426903	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Onabotulinumtoxin A vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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