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

January 25, 2023 updated by: Cutera Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physician's Global Assessment
Time Frame: 12 weeks
Percentage of hair reduction
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse device effects
Time Frame: 12 weeks
Assessment of ADEs immediately following each laser treatment and at the final follow-up visit
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cutera Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C-15-HR-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Study terminated

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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