Safety for Frequent Use Conditions of Hair Removal Device (OHR-3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Syneron Medical
ClinicalTrials.gov Identifier:
NCT01348789
First received: May 4, 2011
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Hair Removal
Device: Hair2Go (Mē)

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Hair2Go Device in Frequent Use Conditions: A Prospective, Open Label Study With Before-After Design

Further study details as provided by Syneron Medical:

Primary Outcome Measures:
  • Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. [ Time Frame: 0, 3, 7 days (after treatment #1, #2, and #3 respectively) ] [ Designated as safety issue: No ]
    Subject self-report of the tolerability of the procedure (no pain, mild pain, moderate pain) after each of the treatments (#1, #2, #3)separately for relatively light and dark skin photo-types (I-IV and V-VI respectively according to Fitzpatrick skin photo-type classification)

  • Hair Clearance [ Time Frame: 8 weeks after last treatment ] [ Designated as safety issue: No ]
    Hair Clearance = the percent of hair cleared from baseline to follow up


Enrollment: 37
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hair2Go (Mē)
Treatment with Hair2Go (Mē)device
Device: Hair2Go (Mē)
Treatment with Hair2Go (Mē) three times every 2-4 days
Other Name: Mē my elōs

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348789

Locations
United States, Illinois
Physician Laser and Dermatology Institute
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Syneron Medical
Investigators
Principal Investigator: Jerome M Garden, MD Northwestern Memorial Hospital
  More Information

No publications provided

Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT01348789     History of Changes
Other Study ID Numbers: OHR-3
Study First Received: May 4, 2011
Results First Received: December 4, 2012
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Syneron Medical:
Hair removal
Hair Clearance
Epilation

ClinicalTrials.gov processed this record on April 16, 2014