Trial Outcomes & Findings for Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis (NCT NCT02100072)

Last Updated: 2021-01-08

Results Overview

A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. To calculate the change between the baseline and 3 months post baselines, the values taken at these 2 time points are subtracted from each other. A negative value means that there has been a decrease in gravimetric weight since the baseline.

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Baseline and 3 months post baseline

Results posted on

2021-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Nd:YAG 1440 nm Laser Nd:YAG Laser With 1440nm Wavelength. Each subject received 1 treatment using this laser over an approximately 3x4 cm area.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of 1440nm Laser Assisted Selective Photothermolysis for Treatment of Axillary Hyperhidrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nd:YAG 1440 nm Laser n=5 Participants Nd:YAG 1440 nm laser
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American	2 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type I	0 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type II	0 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type III	3 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type IV	0 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type V	2 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type VI	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months post baseline

Population: 1 subject was incapable of attending the follow up visit, so their gravimetric measurement was not able to be obtained. They were able to answer other follow up questions via the phone, however.

Outcome measures

Outcome measures
Measure	Nd:YAG 1440 nm Laser n=4 Participants Nd:YAG Laser With 1440nm Wavelength. Each subject received 1 treatment using this laser over an approximately 3x4 cm area.
Change in Sweating Assessed Using Gravimetry Average Gravimetric Change (Left Side)	-104.50 mg Standard Deviation 156.57
Change in Sweating Assessed Using Gravimetry Average Gravimetric Change (Right Side)	-90.85 mg Standard Deviation 131.84

Adverse Events

Nd:YAG 1440 nm Laser

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nd:YAG 1440 nm Laser n=5 participants at risk Nd:YAG 1440 nm laser
Skin and subcutaneous tissue disorders Sweat	20.0% 1/5 • Adverse Events occurring were captured and followed throughout the study duration, approximately 3 months.
Nervous system disorders Numbness	40.0% 2/5 • Adverse Events occurring were captured and followed throughout the study duration, approximately 3 months.
Skin and subcutaneous tissue disorders Bruising	20.0% 1/5 • Adverse Events occurring were captured and followed throughout the study duration, approximately 3 months.
Skin and subcutaneous tissue disorders Itching	20.0% 1/5 • Adverse Events occurring were captured and followed throughout the study duration, approximately 3 months.
Nervous system disorders Pain	40.0% 2/5 • Adverse Events occurring were captured and followed throughout the study duration, approximately 3 months.
Skin and subcutaneous tissue disorders Redness	20.0% 1/5 • Adverse Events occurring were captured and followed throughout the study duration, approximately 3 months.
Skin and subcutaneous tissue disorders Swelling	20.0% 1/5 • Adverse Events occurring were captured and followed throughout the study duration, approximately 3 months.

Additional Information

Jamie Trimper

Cynosure

Phone: 800-886-2966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
Publication restrictions are in place

Restriction type: OTHER