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CompletedNCT02103608Updated Sep 10, 2018Results posted

Clinical Evaluation of Silk'n Glide for Face

An interventional study of Glide in Hirsutism, sponsored by Home Skinovations Ltd.. Completed. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by Home Skinovations Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
21 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

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)
02

Conditions studied

  • Hirsutism

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Keywords

  • at Home Photo depilation device, Silk'n.
03

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Presence of unwanted hairs on the face
  2. Skin Type I to IV (Fitzpatrick)
  3. Adults older than 21 years of age but not more than 60 years of age.
  4. 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).
  5. Informed consent agreement by the subject.
  6. Willingness to follow the treatment schedule and post treatment care.

Exclusion criteria

Exclusion Criteria:

  1. Malignant or pre-malignant pigmented lesions in the area to be treated.
  2. Scarring or infection of the area to be treated.
  3. Known photosensitivity.
  4. Pregnancy or lactating
  5. Subjects with Diabetes (Type I or II).
  6. Presence of a suntan in the area to be treated.
  7. Use of medication known to induce photosensitivity.
  8. Subject is on anticoagulative medication or throm-boembolic condition.
  9. Subjects with a pacemaker or internal defibrillator.
  10. Use of NSAIDS two weeks prior to, and two weeks following the treatment.
  11. Subjects that use waxing or other methods of photo-epilation 3 months prior to treatment.
  12. Subjects that have been exposed to strong sunlight or an artificial tanning machine during the past 4 weeks
  13. Subjects wearing a tattoo or permanent makeup on the area to be treated
  14. Subjects with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated
  15. Subjects with Eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated
  16. Subjects with history of keloidal scar formation
  17. Subjects with history of herpes outbreaks in the area of treatment, unless you have consulted your physician and received preventative treatment before using GlideTM
  18. Subjects with epilepsy
  19. Subjects using incontinence device, insulin pump, other active devices [NB: Protocol excludes pace-makers and internal defibrillators.]
  20. Subjects with a history of skin cancer or areas of po-tential skin malignancies
  21. Subjects who have received radiation therapy or chemotherapy treatments within the past 3 months
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Percentage of hair reduction

    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

  • DeviceGlide

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

05

What researchers measure

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.

    Time frame: 4 weeks and 12 weeks post treatment

06

Results

Posted Sep 10, 2018

Participant flow

Participant flow — Overall Study
MilestoneGlide Device
Started17
Completed15
Not completed2

Outcome measures

Primary1. 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.

Time frame:
4 weeks and 12 weeks post treatment
Reported as:
Mean · percentage of hair reduction
1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits.
percentage of hair reductionGlide Device
4 weeks follow up83.3 ± 22.5
12 weeks follow up78.1 ± 34.2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Glide Device0/17 (0%)0/17 (0%)0/17 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Glide Device
<=18 years0
Between 18 and 65 years17
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Glide Device
Female17
Male0
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Glide Device
Region of Enrollment
Region of Enrollment(Participants)Glide Device
United States17
Hair count at baseline
Hair count at baseline(hair strands/cm^2)Glide Device
Mean22.7 ± 14.6
07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Registry details

Key details

Study ID
NCT02103608
Lead sponsor
Home Skinovations Ltd.
Responsible party
Sponsor
First posted
Apr 4, 2014
Start date
Sep 2013
Primary completion
Jul 2014
Completion
Dec 2014
Results posted
Sep 10, 2018
Last update
Sep 10, 2018

Study contacts

Michael H Gold, MD
principal investigator · Tennessee Clinical Research Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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