Hair Removal Clinical Trial
— OHR-3Official title:
Safety of Hair2Go Device in Frequent Use Conditions: A Prospective, Open Label Study With Before-After Design
Verified date | February 2013 |
Source | Syneron Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To measure the safety of hair removal device when used frequently.
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). |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Physician Laser and Dermatology Institute | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Syneron Medical |
United States,
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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