Trial Outcomes & Findings for Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser (NCT NCT01810991)

NCT ID: NCT01810991

Last Updated: 2021-03-04

Results Overview

3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: 3 Month Follow Up
• Results posted on: 2021-03-04

Participant Flow

Participant milestones

Measure	Nd:YAG Laser Nd:YAG 1440nm Laser Nd:YAG Multiwavelength Diode Laser Using 1440nm Wavelength. A Rep Rate of 25 Hz was used. Each subject received 1 treatment using this laser.
Overall Study STARTED	19
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser

Baseline characteristics by cohort

Measure	Nd:YAG Laser n=19 Participants Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser
Age, Categorical <=18 years	0 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=113 Participants
Age, Categorical >=65 years	0 Participants n=113 Participants
Sex: Female, Male Female	13 Participants n=113 Participants
Sex: Female, Male Male	6 Participants n=113 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	1 Participants n=113 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American	2 Participants n=113 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American/Caucasian	1 Participants n=113 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	0 Participants n=113 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	15 Participants n=113 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type I	2 Participants n=113 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type II	8 Participants n=113 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type III	7 Participants n=113 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type IV	1 Participants n=113 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type V	1 Participants n=113 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type VI	0 Participants n=113 Participants

PRIMARY outcome

Timeframe: 3 Month Follow Up

Population: The subject was lost to follow up (not due to adverse events).

3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.

Outcome measures

Measure	Nd:YAG Laser n=18 Participants Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser
Percentage of Photographs Identified Accurately	84.8 % of photographs identified correctly Standard Deviation 5.9

PRIMARY outcome

Timeframe: 6 Month Follow Up

Population: Anything beyond the 3 month follow up was not required, and the subject chose not to come in.

3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.

Outcome measures

Measure	Nd:YAG Laser n=17 Participants Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser
Percentage of Photographs Identified Accurately	87.2 % of photographs identified correctly Standard Deviation 12.3

SECONDARY outcome

Timeframe: up to 3 months post last treatment

Population: The biopsy portion of the study was optional, so there were only 5 subjects.

Hematoxylin and eosin (H&E) staining was performed on all pre and post treatment biopsy samples and evaluated by a pathologist to determine if there was any change in the subjects' glands at baseline vs. post last treatment. Changes in glands are characterized by reduction in quantity and size, in addition to changes in shape.

Outcome measures

Measure	Nd:YAG Laser n=5 Participants Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser
Number of Participants With Changed and Unchanged Glands on Biopsy Sampling # of Participants with Only Unchanged Glands	3 Participants
Number of Participants With Changed and Unchanged Glands on Biopsy Sampling # of Participants with Changed Glands	2 Participants

Adverse Events

Nd:YAG Laser

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nd:YAG Laser n=19 participants at risk Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser
Nervous system disorders Numbness	94.7% 18/19 • Adverse events were collected for the study duration, around 12 months.
Nervous system disorders Pain	100.0% 19/19 • Adverse events were collected for the study duration, around 12 months.
Skin and subcutaneous tissue disorders Redness	94.7% 18/19 • Adverse events were collected for the study duration, around 12 months.
Skin and subcutaneous tissue disorders Swelling	94.7% 18/19 • Adverse events were collected for the study duration, around 12 months.
Skin and subcutaneous tissue disorders Bruising	100.0% 19/19 • Adverse events were collected for the study duration, around 12 months.
Skin and subcutaneous tissue disorders Itching	78.9% 15/19 • Adverse events were collected for the study duration, around 12 months.
Skin and subcutaneous tissue disorders Nodule	0.00% 0/19 • Adverse events were collected for the study duration, around 12 months.
Skin and subcutaneous tissue disorders Blister	5.3% 1/19 • Adverse events were collected for the study duration, around 12 months.
Skin and subcutaneous tissue disorders Hardness	0.00% 0/19 • Adverse events were collected for the study duration, around 12 months.

Additional Information

Jamie Trimper

Cynosure

Phone: 800-886-2966

Email: jamie.trimper@cynosure.com

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