Clinical trial NCT01348789: Safety for Frequent Use Conditions of Hair Removal Device
Official title: Safety of Hair2Go Device in Frequent Use Conditions: A Prospective, Open Label Study With Before-After Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Removal
Keywords: Hair removal
Hair Clearance
Epilation
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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).

Primary outcomes:
measure: Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.
timeFrame: Up to 3 months
Secondary outcomes:
measure: Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.
timeFrame: 0, 3, 7 days (after treatment #1, #2, and #3 respectively)
measure: Hair Clearance
timeFrame: 8 weeks after last treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Physician Laser and Dermatology Institute
state: Illinois
Study officials:
affiliation: Northwestern Memorial Hospital
name: Jerome M Garden, MD
role: PRINCIPAL_INVESTIGATOR
References: