Safety for Frequent Use Conditions of Hair Removal Device

Completed · Not applicable

Conditions studied: Hair Removal

In brief

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

Key facts

Study ID

NCT01348789

Run by

Syneron Medical

People needed

37

Starts

2011-03-01

Expected to finish

2012-06-01

Last updated by the study team

2013-02-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Physician Laser and Dermatology Institute — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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