Safety for Frequent Use Conditions of Hair Removal Device

NCT ID: NCT01348789

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-06-30

Brief Summary

To measure the safety of hair removal device when used frequently.

Detailed Description

The primary endpoint of this study is to measure the safety of the Hair2Go device when used frequently. The secondary endpoints include the kinetics of the hair clearance up to 8 weeks after the last treatment, and gathering information about the pain associated with the procedure

Conditions

Hair Removal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hair2Go (Mē)

Treatment with Hair2Go (Mē)device

Group Type: EXPERIMENTAL

Hair2Go (Mē)

Intervention Type: DEVICE

Treatment with Hair2Go (Mē) three times every 2-4 days

Interventions

Hair2Go (Mē)

Treatment with Hair2Go (Mē) three times every 2-4 days

Intervention Type: DEVICE

Other Intervention Names

Mē my elōs

Eligibility Criteria

Inclusion Criteria

• Healthy males and females, between 18 and 65 years of age.
• Willing to sign informed consent.
• Willing to follow the treatment schedule and post treatment follow-up.
• Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
• Willingness to avoid excessive sun exposure two weeks prior treatments

Exclusion Criteria

• A history of keloidal scarring (hypertrophic scars or keloids).
• Active dermatologic lesion or infection in the treatment site.
• Subject has permanent tattoos or makeup in the treatment area.
• Recently tanned in the area to be treated and/or unable or unlikely to refrain from tanning during the study.
• Subject has disease related to photosensitivity, such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc
• Subject has a history of herpes outbreak in the area of treatment, unless receiving preventative treatment from physician
• Pregnant, planning to become pregnant, hormone fluctuations and/or breast feeding during the experiment.
• Subjects with Diabetes (Type I or II) or other systemic or metabolic condition
• Subject has an active electrical implant anywhere in the body, such as a pacemaker, an internal defibrillator, insulin pump, incontinence device, etc.
• Subject suffers from epilepsy.
• Subject has active cancer, or has a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions.
• Subject received radiation therapy or chemotherapy treatments with the past 3 months.
• Subject has known anticoagulative or thromboembolic condition or is on any form of anticoagulation treatment.
• Subject has a history of immunosuppressant/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• Subject has any other condition which in the physician's opinion would make it unsafe for the subject to be treated.
• Subject had rotating type tweezer epilator treatment, or waxing within the last 3 months
• Subject had electrolysis treatment within the last 6 months over the treatment area.
• Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment site within the last 6 months.
• Participation in a study of another device or drug within 1 month prior to enrollment or during this study.
• Subject is taking medication known to induce photosensitivity, including non-steroidal anti-inflammatory agents, tetracyclines, phenothiazines, thiazide diuretics, sulfonylureas, sulfonamides, Dacarbazine (DTIC), fluorouracil, vinblastine, and griseofulvin within 4 weeks of therapy.
• Subject has been taking Accutane® within 6 months of therapy.
• Subject has been on steroid regimen during the last three months.
• Subject is on Gold therapy (for arthritis treatment).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneron Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerome M Garden, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Memorial Hospital

Locations

Physician Laser and Dermatology Institute

Chicago, Illinois, United States

Countries

United States

Other Identifiers

OHR-3

Identifier Type: -

Identifier Source: org_study_id