A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal

To evaluate the safety and efficacy of the Cutera excel HR dual wavelength 755nm Alexandrite and 1064nm Nd:YAG laser for hair removal.

Study Overview

• Status: Withdrawn
• Conditions: Hypertrichosis
• Intervention / Treatment: Device: 755nm and 1064nm Nd:YAG laser

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Squamish, British Columbia, Canada, V5B0C1
      • Lezara Laser & Vein Care
    • Surrey, British Columbia, Canada, V4P1B7
      • Body Bar Laser Clinic/Academy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 755nm and 1064nm Nd:YAG laser	Device: 755nm and 1064nm Nd:YAG laser; Dual wavelength 755nm and 1064nm Nd:YAG laser; Other Names: Excel HR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician's Global Assessment	Percentage of hair reduction	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse device effects	Assessment of ADEs immediately following each laser treatment and at the final follow-up visit	12 weeks

Collaborators and Investigators

• Sponsor: Cutera Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimate): August 31, 2015

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Hypertrichosis
• Other Study ID Numbers: C-15-HR-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Study terminated