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

NCT02536092 | Withdrawn

• 1 other identifier: C-15-HR-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertrichosis

Outcome Measures

Primary Outcomes (1)

• Physician's Global Assessment

  Percentage of hair reduction

  12 weeks

Secondary Outcomes (1)

• Incidence and severity of adverse device effects

  12 weeks

Study Arms (1)

755nm and 1064nm Nd:YAG laser

EXPERIMENTAL

755nm and 1064nm Nd:YAG laser

Device: 755nm and 1064nm Nd:YAG laser

Interventions

755nm and 1064nm Nd:YAG laser DEVICE

Dual wavelength 755nm and 1064nm Nd:YAG laser

Also known as: Excel HR

755nm and 1064nm Nd:YAG laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (2)

Lezara Laser & Vein Care

Squamish, British Columbia, V5B0C1, Canada

Location

Body Bar Laser Clinic/Academy

Surrey, British Columbia, V4P1B7, Canada

Location

MeSH Terms

Conditions

Hypertrichosis

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: August 31, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)