Safety for Frequent Use Conditions of Hair Removal Device

NCT01348789 | Completed Results DMC

• 1 other identifier: OHR-3
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hair Removal

Keywords

Hair removal; Hair Clearance; Epilation

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.

  The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes: * Presence of transient (disappearing \< 24 hours) or prolonged erythema * Presence of transient (disappearing \< 24 hours) or prolonged edema * Self-limited bleeding from mechanical shaving * Blister formation * Ulcer formation * Pigment changes (hypo/hyper) * Textural changes * Scarring * Infection * Pruritis * Post inflammation reactions * Allergic reaction The safety of the device will be confirmed if no device related serious adverse event will occur.

  Up to 3 months

Secondary Outcomes (2)

• Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.

  0, 3, 7 days (after treatment #1, #2, and #3 respectively)

• Hair Clearance

  8 weeks after last treatment

Study Arms (1)

Hair2Go (Mē)

EXPERIMENTAL

Treatment with Hair2Go (Mē)device

Device: Hair2Go (Mē)

Interventions

Hair2Go (Mē) DEVICE

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

Also known as: Mē my elōs

Hair2Go (Mē)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

Physician Laser and Dermatology Institute

Chicago, Illinois, 60611, United States

Location

Results Point of Contact

• Title: Dr. Jerome M. Garden
• Organization: Northwestern Memorial Hospital

j-garden@northwestern.edu

312-280-0891

Study Officials

• Jerome M Garden, MD

  Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: May 4, 2011
• First Posted: May 5, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 18, 2013
• Results First Posted: February 18, 2013

Record last verified: 2013-02

Locations

US (1)