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NCT Number: NCT04546438

Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis

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.

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Key information

Conditions

Axillary Hyperhidrosis Behavior Behavioral Symptoms Depression Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrinnevisjukhuset

Norrköping, 60379, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

miraDry®

Device

MiraDry is a noninvasive method that uses microwave technology to destroy sweat glands.

In this study we evaluate a higher energy level with a newer generation device, in respect with side effects and number of treatments (one or two interventions).

Primary outcomes

  1. The effectiveness of miraDry treatment

    Time frame: 1 year

    The effect of the treatment will be measured by the participants completing the Hyperhidrosis Disease Severity Scale (score 1 to 4, where a score of 3 or 4 indicates severe hyperhidrosis and a score of 1 or 2 indicates mild or moderate hyperhidrosis) att baseline (prescreening), at 3 month follow-up visit and 1 year follow-up visit.

Secondary outcomes

  1. Frequency of side effects

    Time frame: 1 year

    Short and long term effects will be assessed during treatment and by follow -up telephone visits 2 weeks after the treatment(s), at 3 month follow-up and 1 year follow-up.

  2. Dermatology Life Quality Index assessment

    Time frame: 1 year

    The participants will be asked to complete the Dermatology Life Quality Index, calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The paticipants will complete the questionnaire at baseline, at 3 months follow-up visit and 1 year follow-up visit.

  3. Hospital anxiety and depression scale assessment

    Time frame: 1 year

    The participants will be asked to complete the questionnaire at baseline, at 3 months follow-up visit and 1 year follow-up visit. The questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.

  4. Hyperhidrosis Quality of Life Index assessment

    Time frame: 1 year

    The participants will be asked to complete the Hyperhidrosis Quality of Life Index at baseline, at 3 months follow-up visit and 1 year follow-up visit. There are 18 items and score ranges from 0 to 36, with higher scores indicating a lower Hyperhidrosis Quality of Life Index.

Sponsors and collaborators

Lead sponsor

Region Östergötland

Other

Registry information

Official study title

Patient Quality of Life and Safety of Treatment With Microwave Technology for Axillary Hyperhidrosis

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2020
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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