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OpenTrials
Completed

NCT Number: NCT01348789

Safety for Frequent Use Conditions of Hair Removal Device

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

Completed

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physician Laser and Dermatology Institute

Chicago, Illinois, 60611, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Hair2Go (Mē)

Device

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

Other names: Mē my elōs

Primary outcomes

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

    Time frame: Up to 3 months

    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 outcomes

  1. 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)

    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)

  2. Hair Clearance

    Time frame: 8 weeks after last treatment

    Hair Clearance = the percent of hair cleared from baseline to follow up

Sponsors and collaborators

Lead sponsor

Syneron Medical

Industry

Registry information

Official study title

Safety of Hair2Go Device in Frequent Use Conditions: A Prospective, Open Label Study With Before-After Design

Acronym: OHR-3

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 5, 2011
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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