Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03007004
• Date of registration: 28/12/2016
• Prospective Registration: No
• Primary sponsor: Gunma University
• Public title: Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic Sclerosis
• Scientific title: Trial to Confirm the Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic Sclerosis
• Date of first enrolment: December 12, 2016
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03007004
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Japan

Contacts

• Name: Sei-ichiro Motegi
• Affiliation: Gunma University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients diagnosed with SSc in diagnostic criteria (Appendix 1) by the
American-European Rheumatology Association

2. Patients who have Raynaud's phenomenon from consultation, inquiries, etc. judged by
Clinical responsibility (sharing) doctor

3. Patients with digital ulcer at acquiring consent The criteria for digital ulcers are
as follows.

- It is a peripheral ulcer from the proximal interphalangeal joint and the thumb
interphalangeal joint (including the interphalangeal joint).

- The continuity of coating by the epithelium has been lost and there is a depth
that is visible to the eye. Incidentally, when exposed, cases covered with eschar
or necrotic tissue are also included.

- If the exposure is not clearly recognized (crusted or covered with necrotic
tissue), the investigational responsibility (shared) doctor can judge that the
epidermis and the dermis are missing.

- It should not be the paronychia?crack?digital pitting scars.

- It should not be attached to the projection of the calcification.

- Size: The maximum diameter (major axis) is 0.5 cm or more.

- Bones, tendons and joints are not exposed.

- It is not accompanied by obvious infection findings.

4. At the time of acquiring consent Patients over 18 years old

5. Patients for whom consent has been obtained in writing on participation of this trial

Exclusion Criteria:

1. Patients with Raynaud's phenomenon due to diseases other than SSc

2. Patients with systemic neuromuscular junction disorder (myasthenia gravis,
Lambert-Eaton syndrome, amyotrophic lateral sclerosis etc.)

3. Patients with advanced respiratory dysfunction

4. Patients with a history of hypersensitivity to components of botulinum toxin type B
(botulinum toxin type B, human serum albumin, succinate buffer) or other botulinum
toxin

5. Patients who received botulinum toxin formulation within 4 months before study drug
administration or who have continued efficacy of botulinum toxin at the time of
administration of investigational drug even when administered more than 4 months ago

6. Patients who received endothelin receptor antagonist within 60 days before study drug
administration

7. Patients who received the following medications within 14 days prior to study drug
administration

- Argatroban hydrate injection

- Prostaglandin E1 Injection (eg alprostadil injection)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Sclerosis Patients With Digital Ulcers

Intervention(s)

Drug: Physiological saline

Drug: Botulinum toxin type B (2500 units / vial)

Primary Outcome(s)

Percentage of subjects who completely lost index ulcer 8 weeks after administration [Time Frame: 8 weeks after administration]

Secondary Outcome(s)

the changes of the recovery of skin temperature in the finger with the index ulcer [Time Frame: at 4, 8, 12, and 16 weeks after administration]

the changes in the attack duration of Raynaud's phenomenon [Time Frame: at 4, 8, 12, and 16 weeks after administration]

the percentage of subjects with complete disappearance of index ulcer at 4, 12, and 16 weeks after administration [Time Frame: at 4, 12, and 16 weeks after administration]

the changes in RP severity were assessed using Raynaud's Condition Score [RCS] [Time Frame: at 4, 8, 12, and 16 weeks after administration]

the rate of change in the number of DUs per hand [Time Frame: at 4, 8, 12, and 16 weeks after administration]

the number of newly formed DUs [Time Frame: at 4, 8, 12, and 16 weeks after administration]

the changes in the number of attacks of Raynaud's phenomenon per day [Time Frame: at 4, 8, 12, and 16 weeks after administration]

the changes in the score of pain/numbness severity assessed using the 100-mm Visual Analog Scale (VAS) [Time Frame: at 4, 8, 12, and 16 weeks after administration]

the changes of investigator rating Raynaud's Condition Score [RCS] [Time Frame: at 4, 8, 12, and 16 weeks after administration]

the number of newly formed DUs per hand [Time Frame: at 4, 8, 12, and 16 weeks after administration]

Secondary ID(s)

D2016017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors