The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01348776|
Recruitment Status : Completed
First Posted : May 5, 2011
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
|Condition or disease||Intervention/treatment|
|Hair Removal||Device: Hair2Go (Mē)|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design|
|Study Start Date :||March 2011|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
Experimental: Hair2Go (Mē)
Subjects treated with Hair2Go (Mē) Device
Device: Hair2Go (Mē)
Treatment with Hair2Go Device 7 times every week with maintenance treatments once a month for 3 months
Other Name: Mē my elōs
- Hair Clearance 1 Month After Last Treatment [ Time Frame: 3 months (1 month after 7 weekly treatments) ]Hair clearance = the percent of hair cleared from baseline to endpoint.
- Hair Clearance at 3-month (Final) Follow up [ Time Frame: 5 months (3 months after 7 weekly treatments) ]Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments.
- Occurrence of Anticipated Effects on Skin [ Time Frame: Up to 19 weeks ]As with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.
- Tolerability Level of the Procedure Following Treatments [ Time Frame: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3) ]
Gathering information about the tolerability of the procedure following weekly treatments 1, 3, 7 and maintenance treatment 3 by asking subjects to rate the tolerability of the procedure based on 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable [had to stop treatment]) .
The distribution of the tolerability level is based on the analysis of the areas treated and not on the number of participants since each participant was treated on more than one area. Therefore the number of treated areas exceeds the number of participants and the unit of measurement is % treated areas that were rated.
- Subject Satisfaction [ Time Frame: 5 months (final follow up) ]Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348776
|United States, California|
|South Coast Dermatology|
|Tustin, California, United States, 92780|
|United States, Illinois|
|Dr Jerome Garden|
|Chicago, Illinois, United States, 60611|
|United States, Minnesota|
|Zel Skin and Laser Specialist|
|Edina, Minnesota, United States, 55435|
|United States, Tennessee|
|Tennessee Clinical Research Center|
|Nashville, Tennessee, United States, 37215|
|Principal Investigator:||Jerome M Garden, MD||Northwestern Memorial Hospital|
|Principal Investigator:||Vince Afsahi, MD||South Coast Dermatology Institute|
|Principal Investigator:||Brian D Zelickson, MD||Abbot Northwestern Hospital Center for Cosmetic Care|
|Principal Investigator:||Michael Gold, MD||Tennessee Clinical Research Center|