drugset / Trial / NCT03054480
Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis
RandomizedParallel-groupSingle-blindTreatment
Summary
Because of the limiting data about an efficacy and safety of fractional radiofrequency for the treatment of hyperhidrosis, this study aim to compare clinical efficacy by Hyperhidrosis Disease Severity Score (HDSS) between Fractional Microneedle Radiofrequency device and intradermal Botulinum toxin type A injection for the treatment of primary axillary hyperhidrosis. The secondary objectives to determine the improvement change of iodine starch test, total amount of sweat production by trans-epidermal water loss (TEWL), patient's satisfaction and their quality of life by Dermatology Life Quality Index and side effect between the groups.
Timeline
- Start
- 2016-08-01
- Primary completion
- 2016-12-31
- Completion
- 2017-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 50 iu | Other |