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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01348789
Other study ID # OHR-3
Secondary ID
Status Completed
Phase N/A
First received May 4, 2011
Last updated February 15, 2013
Start date March 2011
Est. completion date June 2012

Study information

Verified date February 2013
Source Syneron Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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).

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Hair2Go (Me)
Treatment with Hair2Go (Me) three times every 2-4 days

Locations

Country Name City State
United States Physician Laser and Dermatology Institute Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Syneron Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. 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) 0, 3, 7 days (after treatment #1, #2, and #3 respectively) No
Secondary Hair Clearance Hair Clearance = the percent of hair cleared from baseline to follow up 8 weeks after last treatment No
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Active, not recruiting NCT02318654 - Ice Versus EMLA for Pain in Laser Hair Removal N/A
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