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Botulinum toxin-loaded detachable dissolvable microneedles for primary axillary hyperhidrosis: A pilot study on efficacy and safety

A study of efficacy and safety of Botox-loaded Dissolvable Microneedles for reduction in axillary sweat

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201230002
Enrollment
10
Registered
2020-12-30
Start date
2022-02-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

axillary sweating Microneedle Transdermal Botulinum Toxin Botox Patch test

Interventions

Botox-loaded Dissolvable Microneedles ,Dissolvable microneedles without any active ingredients
Active Comparator Drug,Placebo Comparator Drug
Botox-loaded Dissolvable Microneedles ,Dissolvable microneedles

Sponsors

Material and Bio interface
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. female, aged 18-60 years 2. able to comply with study protocol 3. willingly inform consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactPravit Asawanonda

Chulalongkorn University

fibrosis@gmail.com66818129393

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026