MedPath

Fractionated microneedle radiofrequency versus botuinum toxin A in primary axillary hyperhidrosis

Phase 1
Recruiting
Conditions
Skin and Connective Tissue Diseases
Registration Number
PACTR201808213089174
Lead Sponsor
Reem Osama Eid
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
20
Inclusion Criteria

1.Patients older than 18 years.
2.Patients with bilateral PAH grade 3 and 4 hyoerhidrosis disease severity score (HDSS)

Exclusion Criteria

1.History of surgery for PAH.
2.History of botulinum toxin therapy within the previous 6 months.
3.History of pacemaker implantation or any other electronic implants.
4.Active infection in the treatment area.
5.Tendency for keloid formation.
6.Pregnancy or breastfeeding.
7.Neuromuscular disease e.g. myasthenia gravis.
8.Known hypersensitivity from Botulinum toxin.
9.Autoimmune disease.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparative clinical effectiveness at 1, 2, 3 and 6 months, in the form of reduction of sweating in the treated site
Secondary Outcome Measures
NameTimeMethod
1.Comparative safety of both interventions during the procedure, short-term (0-6 months) and long-term (6-12 months).<br>2.Long-term comparative clinical effectiveness (6-12 months)<br>
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