Botulinum toxin-loaded detachable dissolvable microneedles for primary axillary hyperhidrosis: A pilot study on efficacy and safety
Phase 1
Completed
- Conditions
- axillary sweatingMicroneedle Transdermal Botulinum Toxin Botox Patch test
- Registration Number
- TCTR20201230002
- Lead Sponsor
- Material and Bio interface
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 10
Inclusion Criteria
1. female, aged 18-60 years
2. able to comply with study protocol
3. willingly inform consent
Exclusion Criteria
1. unable to stop previous treatment (washout period of laser/photo is 4 weeks, washout period of topical treatment is 2 weeks)
2. HDSS 2-4
3. have other inflammatory disease/infection at treatment site
4. Pregnant or lactating women
5. allergic to topical anesthesia and iodine
6. heartblock disease
7. immunocompromised patients
8. psychologic patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sweating reduction, determined by score of iodine starch test Day 0 ,Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 iodine starch test
- Secondary Outcome Measures
Name Time Method Patient Satisfaction Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 Patient Satisfaction Score,Pain score Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 Visual analogue scale,Doctor Satisfaction Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 Doctor Satisfaction Score,Side effects Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 Physical examination