Physician Laser and Dermatology Institute
Chicago, Illinois, 60611, United States
NCT Number: NCT01348789
To measure the safety of hair removal device when used frequently.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment with Hair2Go (Mē) three times every 2-4 days
Other names: Mē my elōs
Time frame: Up to 3 months
The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes:
The safety of the device will be confirmed if no device related serious adverse event will occur.
Time frame: 0, 3, 7 days (after treatment #1, #2, and #3 respectively)
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)
Time frame: 8 weeks after last treatment
Hair Clearance = the percent of hair cleared from baseline to follow up
Syneron Medical
Industry
Safety of Hair2Go Device in Frequent Use Conditions: A Prospective, Open Label Study With Before-After Design
Acronym: OHR-3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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