Clinical trial NCT04546438: Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis
Official title: Patient Quality of Life and Safety of Treatment With Microwave Technology for Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axillary Hyperhidrosis
Keywords: hyperhidrosis
hyperhidrosis disease severity scale (HDSS)
Hospital Anxiety and Depression Scale (HADS)
DLQI
HYPERHIDROSIS QUALITY OF LIFE INDEX (HidroQoL)
microwave
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary localized hyperhidrosis is a dermatological disorder that involves excessive sweat production without an underlying cause. The disease usually affects the axillae but can also involve palms, soles of the feet or face and causes major problems in many social situations with a negative impact on quality of life and mental health.

In this study, the investigators want to investigate the effect of microwave therapy (MiraDry®) on self-rated sweating, quality of life and anxiety in participants with severe axillary hyperhidrosis. The study also aims to evaluate the safety (side effects) of the method and long term effects over 1 year of follow upp.

Detailed description: The study is conducted during several visits or telephone follow-ups at the clinic over a period of 12 months and each patient receives a maximum of two treatments with MiraDry® (at 3-month intervals). 100 participants are planned to participate in the study.

The primary objective is to evaluate the effectiveness of the miraDry ® treatment measured by Hyperhidrosis Disease Severity Scale(HDSS).

Secondary objectives are to evaluate the side effects and the quality of Life by assessment of The Dermatology life Quality Index, The Hyperhidrosis Quality of Life Index, and Hospital Anxiety and Depression Scale.

Eligibility criteria: Inclusion Criteria:

* This study will recruit participants diagnosed with primarily axillary hyperhidrosis
* Informed consent is required.
* HDSS 3 or 4 (the criteria used in Sweden to allow hospital-based intervention).

Exclusion Criteria:

Participants

* who are unable to provide informed consent,
* have known allergies to lidocaine, chlorhexidine, and/or epinephrine,
* are pregnant,
* are unable to take oral antibiotics or antiseptic washes,
* have heart pacemakers or other electronic device implants,
* who need supplemental oxygen,
* have had axillary surgery procedures for hyperhidrosis,
* with previous hidradenitis suppurativa or other local infections
* had previous cancer in the treated area are not eligible to participate in this study

Primary outcomes:
measure: The effectiveness of miraDry treatment
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of side effects
timeFrame: 1 year
measure: Dermatology Life Quality Index assessment
timeFrame: 1 year
measure: Hospital anxiety and depression scale assessment
timeFrame: 1 year
measure: Hyperhidrosis Quality of Life Index assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Vrinnevisjukhuset
Study officials:
affiliation: Region Östergötland
name: Emanuela Micu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: