Clinical Evaluation of Silk'n Glide for Face

NCT02103608 | Completed Results DMC

• 1 other identifier: DO105306A
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hirsutism

Keywords

at Home Photo depilation device, Silk'n.

Outcome Measures

Primary Outcomes (1)

• 1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits.

  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.

  4 weeks and 12 weeks post treatment

Study Arms (1)

Percentage of hair reduction

EXPERIMENTAL

This is an open label, prospective study to evaluate safety and efficiency of Silk'n Glide on the face. During the study, 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 .

Device: Glide

Interventions

Glide DEVICE

6 facial hair reduction treatments with the Glide device, two weeks apart.

Percentage of hair reduction

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of unwanted hairs on the face
• Skin Type I to IV (Fitzpatrick)
• Adults older than 21 years of age but not more than 60 years of age.
• Must be either post-menopausal or surgically steri-lized, or using a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or absti-nence).
• Informed consent agreement by the subject.
• Willingness to follow the treatment schedule and post treatment care.

You may not qualify if:

• Malignant or pre-malignant pigmented lesions in the area to be treated.
• Scarring or infection of the area to be treated.
• Known photosensitivity.
• Pregnancy or lactating
• Subjects with Diabetes (Type I or II).
• Presence of a suntan in the area to be treated.
• Use of medication known to induce photosensitivity.
• Subject is on anticoagulative medication or throm-boembolic condition.
• Subjects with a pacemaker or internal defibrillator.
• Use of NSAIDS two weeks prior to, and two weeks following the treatment.
• Subjects that use waxing or other methods of photo-epilation 3 months prior to treatment.
• Subjects that have been exposed to strong sunlight or an artificial tanning machine during the past 4 weeks
• Subjects wearing a tattoo or permanent makeup on the area to be treated
• Subjects with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated
• Subjects with Eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated

Sponsors & Collaborators

• Home Skinovations Ltd.: lead

MeSH Terms

Conditions

Hirsutism

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michael Gold
• Organization: Tennesse clinical research center

drgold@goldskincare.com

615-383-2400

Study Officials

• Michael H Gold, MD

  Tennessee Clinical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2014
• First Posted: April 4, 2014
• Study Start: September 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 10, 2018
• Results First Posted: September 10, 2018

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share