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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014