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Treatment of axillary hyperhidrosis by Microneedle Radiofrequency.

Clinical trial of the effect of Fractionated Microneedle Radiofrequency in the treatment of severe primary axillary hyperhidrosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013111915455N1
Enrollment
25
Registered
2014-01-23
Start date
2013-10-31
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Axillary hyperhidrosis. Localized hyperhidrosis

Interventions

Intervention 1: The left axilla was treated with a total of 3 passes of Fractionated Microneedle Radiofrequency. The treatment parameters included : The depth was at 2-3 mm
The energy level was at 6- 10 Jules
The Time was at 120- 180 m sec with a small range (±10%) of variation for energy and time. Intervention 2: The right axilla was treated with a total of 3 passes of Fractionated Microneedle Radiofreque
Treatment - Other
The left axilla was treated with a total of 3 passes of Fractionated Microneedle Radiofrequency. The treatment parameters included : The depth was at 2-3 mm
The Time was at 120- 180 m sec with a small range (±10%) of variation for energy and time.
The right axilla was treated with a total of 3 passes of Fractionated Microneedle Radiofrequency when the device was on standby mode (sham control).

Sponsors

Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Having the complaint Primary Axillary Hyperhidrosis and score 3 or 4 in Hyperhidrosis Disease Severity Scale (HDSS); Age between 18-50 years ; both genders ; Willingness for participation in the study and signing the consent form Exclusion criteria: Pregnant or breast-feeding women ; active infection at the axilla ; taking anticholinergic drug ; heart pace-maker or cardiac defibrillator ; taken botulinum toxin injections in the axillae within the previous 6 months ; Patients who have propensity for keloid formation

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of sweating. Timepoint: 1 and 3 weeks after each session and 3 months after the last session. Method of measurement: Hyperhidrosis Disease Severity Scale (HDSS) - Sweating intensity visual analog scale (VAS).;Patients satisfaction. Timepoint: At base line – at the end of the study. Method of measurement: 6-point scale.

Secondary

MeasureTime frame
Edema. Timepoint: 1 and 3 weeks after each session and 3 months after the last session. Method of measurement: Examination.;Quality of life. Timepoint: At base line – at the end of the study. Method of measurement: Dermatology Life Quality Index (DLQI).;Pigmentation. Timepoint: 1 and 3 weeks after each session and 3 months after the last session. Method of measurement: Examination.;Compensatory hyperhidrosis. Timepoint: 1 and 3 weeks after each session and 3 months after the last session. Method of measurement: Ask the subjects.;Local reactions. Timepoint: 1 and 3 weeks after each session and 3 months after the last session. Method of measurement: Examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr bahareh Abtahi-Naeini

Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira

bahareh.abtahi@yahoo.com+98 31 1264 2901

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 14, 2026