HYPERHIDROSIS
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm wavelength laser for the treatment of primary hyperhidrosis of the axilla.
Interventions
DEVICENd:YAG Laser
Nd:YAG 1440nm Laser
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* A healthy non-smoking male or female between 18-56 years of age * Understand/accept obligation not to receive any other procedures in anatomical areas exhibiting axillary hyperhidrosis through 3 months prior to treatment * Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits * Clinically diagnosed for primary hyperhidrosis of the axilla. * A self assessed Hyperhidrosis Disease Severity Scale (HDSS) score of three (3) or four (4)
Exclusion criteria
* Clinical diagnosis of secondary hyperhidrosis * Uncontrolled systemic disease * Concurrent use of any hyperhidrosis treatments other than over the counter antiperspirants or deodorants * Receipt of Botox or Dysport within the past six months * Patients who refuse to stop using over the counter antiperspirants 24 hours prior to the day of surgery and each of the follow-up visits at 3 months and 6 months that Minors starch iodine tests may be performed. * Patients using or having used within 7 days of baseline visit: cholinomimetic agents, anticholinergic agents, prescription antiperspirants, any herbal medicine treatments or any other treatments for hyperhidrosis except over the counter antiperspirant or planning to use such agents during the course of the study. * Any previous liposuction/liposculpture or any type of surgery for hyperhidrosis; OR any other types of treatments for hyperhidrosis in the area to be treated in the past 6 months or planning to have any treatments for hyperhidrosis or surgery within the treatment area during the course of the study. * Allergies to medication or local anesthesia required for the procedure * A history of thrombophlebitis * A history of acute infections * A history of heart failure * Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment * An intolerance to anesthesia * Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study * Taking medications that are photosensitive * A history of keloid formation * Is pregnant or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the course of the study * Study subjects that can not maintain their pre-study exercise and diet routine over the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Photographs Identified Accurately | 3 Month Follow Up | 3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Changed and Unchanged Glands on Biopsy Sampling | up to 3 months post last treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nd:YAG Laser Nd:YAG 1440nm Laser
Nd:YAG Laser: Nd:YAG 1440nm Laser | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Nd:YAG Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type I | 2 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type II | 8 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type III | 7 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type IV | 1 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type V | 1 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type VI | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American/Caucasian | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 15 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 0 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 19 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Percentage of Photographs Identified Accurately
3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.
Time frame: 3 Month Follow Up
Population: The subject was lost to follow up (not due to adverse events).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nd:YAG Laser | Percentage of Photographs Identified Accurately | 84.8 % of photographs identified correctly | Standard Deviation 5.9 |
Primary
Percentage of Photographs Identified Accurately
3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets.
Time frame: 6 Month Follow Up
Population: Anything beyond the 3 month follow up was not required, and the subject chose not to come in.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nd:YAG Laser | Percentage of Photographs Identified Accurately | 87.2 % of photographs identified correctly | Standard Deviation 12.3 |
Secondary
Number of Participants With Changed and Unchanged Glands on Biopsy Sampling
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.
Time frame: up to 3 months post last treatment
Population: The biopsy portion of the study was optional, so there were only 5 subjects.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nd:YAG Laser | Number of Participants With Changed and Unchanged Glands on Biopsy Sampling | # of Participants with Only Unchanged Glands | 3 Participants |
| Nd:YAG Laser | Number of Participants With Changed and Unchanged Glands on Biopsy Sampling | # of Participants with Changed Glands | 2 Participants |