N/A
N=37
Safety for Frequent Use Conditions of Hair Removal Device
Hair Removal
Bottom Line
View on ClinicalTrials.gov: NCT01348789 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. — 0; 0; 0 percentage of particpants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hair2Go (Mē) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Syneron Medical
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. |
0; 0; 0 | — |
| SECONDARY Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. |
82; 80; 70; 50; 53; 54 | — |
| SECONDARY Hair Clearance |
44.19 | — |
Summary
To measure the safety of hair removal device when used frequently.
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).
Data sourced from ClinicalTrials.gov (NCT01348789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.