Clinical Trial: Clinical Evaluation of Silk'n Glide for Face

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Clinical Evaluation of Silk'n Glide for Face

Brief Summary: This is a clinical study to determine the efficacy and safety of the Glide, hair removal photo-depilation device, for removing facial hairs. During the first stage, the subjects will perform up to 6 face treatments, two weeks apart. The treatment's safety and efficiency will be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment.

Detailed Summary:

Study efficacy assessment:

Comparison of hair counts before treatments to 4 and 12 weeks follow up visits.

Study safety assessment:

  1. Reported errors and near errors using the device
  2. Device malfunctions which relate to device safety
  3. Device related adverse events
  4. Non device related adverse events (secondary endpoint)

Sponsor: Home Skinovations Ltd.

Current Primary Outcome: 1. Comparison of hair counts before treatments to 4 and 12 weeks follow up visits. [ Time Frame: 4 weeks and 12 weeks post treatment ]

Hair count is going to be preformed and base line and compare with the count at 4 weeks and 12 weeks. % of hair reducation is going to be calculated.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Home Skinovations Ltd.

Dates:
Date Received: March 23, 2014
Date Started: September 2013
Date Completion: June 2014
Last Updated: April 3, 2014
Last Verified: March 2014