A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal
Primary Purpose
Hypertrichosis
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
755nm and 1064nm Nd:YAG laser
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrichosis
Eligibility Criteria
Inclusion Criteria:
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - VI (Appendix 3).
- Subject has black or dark brown unwanted hair.
- Subject must be able to read, understand and sign the Informed Consent Form.
- Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- Willing to refrain from shaving the treatment area for 5 days prior to each study visit.
- Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- Must agree not to use hair removal products, such as topical chemical depilatories, or undergo any other hair removal procedure during the study, such as other laser and light therapies or waxing.
- Willing to refrain from excess sun exposure and willing to wear sunscreen on the treatment area during the study (including the follow-up period).
- Be in good health, as determined by the Investigator.
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study
Exclusion Criteria:
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Had any type of professional hair removal procedure, such as laser, light-based, RF or electrolysis, in the treatment area within 12 months of study participation.
- Had other epilation treatment, such as waxing or mechanical epilator, in the treatment area within 6 months of study participation.
- Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study
- History of malignant tumors in the target area.
- Pregnant and/or breastfeeding.
- Having an infection, dermatitis or a rash in the treatment area.
- Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
- Suffering from coagulation disorders or taking prescription anticoagulation medications.
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- Currently using immunosuppressive medications or history of immunosuppression/immune deficiency disorder, such as psoriasis, eczema, vitiligo, systemic lupus erythematosus or scleroderma.
- History of seizure disorders due to light.
- Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
- History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Systemic use of corticosteroid or isotretinoin within 6 months of study participation.
- Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Current smoker or history of smoking within 6 months of study participation.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Sites / Locations
- Lezara Laser & Vein Care
- Body Bar Laser Clinic/Academy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
755nm and 1064nm Nd:YAG laser
Arm Description
755nm and 1064nm Nd:YAG laser
Outcomes
Primary Outcome Measures
Physician's Global Assessment
Percentage of hair reduction
Secondary Outcome Measures
Incidence and severity of adverse device effects
Assessment of ADEs immediately following each laser treatment and at the final follow-up visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02536092
Brief Title
A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal
Official Title
A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor terminated study
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cutera Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of the Cutera excel HR dual wavelength 755nm Alexandrite and 1064nm Nd:YAG laser for hair removal.
Detailed Description
This is a multi-center prospective, open-label, uncontrolled multi-center study of up to 50 male or female subjects, age 18 to 65 years, who desire laser hair removal. Subjects will receive 6 hair removal treatments, spaced 8 weeks apart, and will be followed at 12 weeks post-final treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrichosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
755nm and 1064nm Nd:YAG laser
Arm Type
Experimental
Arm Description
755nm and 1064nm Nd:YAG laser
Intervention Type
Device
Intervention Name(s)
755nm and 1064nm Nd:YAG laser
Other Intervention Name(s)
Excel HR
Intervention Description
Dual wavelength 755nm and 1064nm Nd:YAG laser
Primary Outcome Measure Information:
Title
Physician's Global Assessment
Description
Percentage of hair reduction
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse device effects
Description
Assessment of ADEs immediately following each laser treatment and at the final follow-up visit
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female or Male, 18 to 65 years of age (inclusive).
Fitzpatrick Skin Type I - VI (Appendix 3).
Subject has black or dark brown unwanted hair.
Subject must be able to read, understand and sign the Informed Consent Form.
Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
Willing to refrain from shaving the treatment area for 5 days prior to each study visit.
Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
Must agree not to use hair removal products, such as topical chemical depilatories, or undergo any other hair removal procedure during the study, such as other laser and light therapies or waxing.
Willing to refrain from excess sun exposure and willing to wear sunscreen on the treatment area during the study (including the follow-up period).
Be in good health, as determined by the Investigator.
Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study
Exclusion Criteria:
Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
Had any type of professional hair removal procedure, such as laser, light-based, RF or electrolysis, in the treatment area within 12 months of study participation.
Had other epilation treatment, such as waxing or mechanical epilator, in the treatment area within 6 months of study participation.
Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study
History of malignant tumors in the target area.
Pregnant and/or breastfeeding.
Having an infection, dermatitis or a rash in the treatment area.
Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
Suffering from coagulation disorders or taking prescription anticoagulation medications.
History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
Currently using immunosuppressive medications or history of immunosuppression/immune deficiency disorder, such as psoriasis, eczema, vitiligo, systemic lupus erythematosus or scleroderma.
History of seizure disorders due to light.
Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
Systemic use of corticosteroid or isotretinoin within 6 months of study participation.
Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
Current smoker or history of smoking within 6 months of study participation.
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Facility Information:
Facility Name
Lezara Laser & Vein Care
City
Squamish
State/Province
British Columbia
ZIP/Postal Code
V5B0C1
Country
Canada
Facility Name
Body Bar Laser Clinic/Academy
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V4P1B7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study terminated
Learn more about this trial
A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal
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