Safety for Frequent Use Conditions of Hair Removal Device (OHR-3)
This study has been completed.
Sponsor:
Syneron Medical
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
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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 June 17, 2013