The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design
The purpose of this study is to determine efficiency of Hair2Go device for short-term and long-term removal of unwanted hair adjunctive to shaving using a before-after study design.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design|
- Hair Clearance 1 Month After Last Treatment [ Time Frame: 3 months (1 month after 7 weekly treatments) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.
|Study Start Date:||March 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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
This study is a multicenter study, designed to determine the efficacy of the Hair2Go hair removal device and to compare the extent of hair removal with and without maintenance treatments. Preferably, two anatomical regions to be treated will be selected including the axilla and either the legs (calves) or forearms. The size of the area treated will be approximately 5x5 cm2. Additional areas including the face can be treated according to the subject's request with the PI's discretion but are not mandatory. Subjects will be provided with the device and will be instructed as to the method of usage. The subjects will be expected to self-administer the treatment at the clinic in a "simulated home environment". The duration of the treatment session is approximately 30-60 minutes. Each of the selected anatomical regions (both left and right sides) will be treated with either low, medium, or high Elōs energy level according to the PI's discretion. However all anatomical regions except for the axilla will be treated with either low or medium elōs energy levels only. Only the axilla will be treated up to an energy of 4J//cm2 A defined area of 5x5 cm2cm2 in the leg will not be treated and will serve as a reference for the temporal changes in hair growth that might be subject to factors, including fluctuations in hormone levels. Both sides (left and right) of the same anatomical region will receive the basic treatments. One side will receive 3 additional maintenance treatments in 4 week intervals ("Maintenance" vs "No maintenance" side) until the end of the experiment. More specifically, the study includes up to 11 visits at the clinic: initial consultation, 7 basic treatments in 1 week intervals followed in one side by 3 maintenance treatments, each 4 weeks apart. Follow ups will be conducted at 4 and 12 weeks after the last basic treatment.
Please refer to this study by its ClinicalTrials.gov identifier: 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|