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Treatment of Axillary Hyperhidrosis With Long-pulsed Nd:YAG Laser or IPL

NCT04227691 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-01-21

No results posted yet for this study

Summary

SUMMARY Objective To assess the efficacy of Nd:YAG laser treatment on eccrine sweat production in the axillae of persons experiencing excessive axillary hyperhidrosis.

Design Randomised, within-person controlled clinical trial.

Setting One Dermatology Department, at a University hospital in Denmark, from 2018-20.

Participants A total of 10 participants enrolled after signing informed consent from the patients attending the hyperhidrosis clinic.

Interventions Participants will receive one Nd:YAG laser-treatment of either left or right axilla. The treated area will be cooled with ice during and after laser treatment. Prior to treatment, patients can use lidocaine-prilocaine 5% cream at the treatment site on an optional basis.

Main outcome measures Primary outcome measure will be reduced excessive sweat production (%points) monitored by an iodine-starch test assessed at 1-month follow-up compared to baseline. A 30% reduction in sweat production in the Nd:YAG laser-treatment relative to control, will be considered clinically significant.

Key secondary outcome measures include (1) weighing the sweat by gravimetric testing, (2) patient assessment of sweat production on a Hyperhidrosis Disease Severity Scale (HDSS) - also assessed at 1 month from baseline. Safety around the use of Nd:YAG laser-treatment will be monitored by registering pain during treatment on a visual analogue scale, as well as monitoring of adverse events immediately as well as one week after treatment. As for the purpose of further exploratory analyses (both benefits and harms), all outcome measures will be re-collected 24 months after treatment.

Timelines and dissemination For the collection of the primary data (i.e. primary endpoint being assessed after 1 month), First Patient First Visit (FPFV) will take place in November 2018 and Last Patient Last Visit (LPLV) will be in March 2019.

The investigators plan to present data internationally at e.g. the European Academy of Dermatology and Venerology as well as nationally to the Danish Dermatology Society and to the Hyperhidrosis Patient Association. Results will be published in an internationally recognised peer reviewed (biomedical) journal.

Trial registration: Danish Research Ethics Committee (approved, protocol number: SJ-689); ClinicalTrials.gov: NCT pending (2018-11-22).

Conditions

  • Hyperhidrosis Primary Focal Axilla

Interventions

DEVICE

Long-pulsed Nd Yag laser treatment

One treatment of the assigned axilla with long-pulsed Nd YAG laser treatment in ten patients

DEVICE

IPL treatment

One treatment of the assigned axilla with IPL treatment in ten patients

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Gregor BE Jemec, DmSc, Prof. · Zealand University Hospital - Roskilde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2021-06-01
Completion
2022-06-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04227691 on ClinicalTrials.gov