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

NCT04227691 | Unknown

• 1 other identifier: SJ-689
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

localized hyperhidrosis; Nd YAG laser treatment; OCT scan; Axillary hyperhidrosis; IPL

Outcome Measures

Primary Outcomes (1)

• Change in sweat production measured by Iodine-starch test

  Reduction of sweat area measured by the percentage reduction of dark-colored area in the axilla one month after treatment measured by the iodine-starch test

  from baseline to one-month post-treatment

Secondary Outcomes (3)

• Change in sweat production measured by Gravimetric testing

  from baseline to one-month post-treatment

• Change in hyperhidrosis disease severity scale (HDSS)

  from baseline to one-month post-treatment

• OCT scan of laser-tissue interactions

  from baseline to one-month post-treatment

Study Arms (2)

Long-pulsed Nd YAG laser treatment

ACTIVE COMPARATOR

Ten patients will be randomized to receive Long-pulsed Nd:YAG in either left or right axilla. (The other axilla will serve as within-person control)

Device: Long-pulsed Nd Yag laser treatment

IPL treatment

ACTIVE COMPARATOR

Ten patients will be randomized to receive IPL treatment in either left or right axilla. (The other axilla will serve as within-person control)

Device: IPL treatment

Interventions

Long-pulsed Nd Yag laser treatment DEVICE

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

Long-pulsed Nd YAG laser treatment

IPL treatment DEVICE

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

IPL treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Legally competent
• women and men
• At least 18 years
• Fitzpatrick skin type I-III
• Suffering from severe axillary hyperhidrosis characterised by a value of 3 or 4 on the HDDS scale.

You may not qualify if:

• Use of photosensitizing medication
• Active treatments for axillary hyperhidrosis within the last five months.
• Wounds, scars or skin disease in the Axillae
• Prior surgery, laser or microwave therapy in the axilla
• Pregnancy or lactation

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital Roskilde

Roskilde, 4000, Denmark

Location

Study Officials

• Gregor BE Jemec, DmSc, Prof.

  Zealand University Hospital - Roskilde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, DmsC, Head of Dpt.

Model Details: Twenty patients are enrolled. Each patient is randomized to receive treatment in left or right axilla with either IPL or Nd:YAG. Thus, it is a within-person randomised trial, where patients receive one treatment in one axilla and the opposite axilla serve as a control.

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 14, 2020
• Study Start: January 17, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)