Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece

NCT01282866 | Completed Results

• 1 other identifier: LUM- ABU-LSDuet-08-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical study is to verify hair count reduction, associated comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated that the larger treatment size of the HS handpiece will result in faster treatment of larger areas; and that the lower energy levels will result in greater comfort.

Conditions

Hair Removal

Outcome Measures

Primary Outcomes (1)

• Hair Count

  The hair at the treatment area is counted at Baseline and 6 months following the last treatment. Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline.

  6 month following last treatment

Secondary Outcomes (3)

• Treatment Time

  Each treatment

• Level of Comfort Associated With Treatment

  Each treatment

• Hair Count

  15 month following last treatment

Study Arms (1)

HS treatment

EXPERIMENTAL

Treatment with HS handpiece

Device: LightSheer Duet

Interventions

LightSheer Duet DEVICE

LightSheer Duet HS handpiece

HS treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult, female, 18 years of age or older with skin type I-IV;
• Having at least one suitable treatment area for hair removal with brown hair;
• Able and willing to comply with the treatment/follow-up schedule and requirements;
• Able to read, understand and provide written Informed Consent.
• Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to market preference test enrollment and throughout the course of the study treatment.

You may not qualify if:

• Showing symptoms of hormonal disorders, as per the Investigator's discretion;
• Use of oral isotretinoin (Accutane®) within 6 months
• Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
• History of keloid formation or poor wound healing in a previously injured skin area;
• Significant skin conditions affecting treated area or inflammatory skin conditions;
• Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
• Having a history of bleeding disorder or taking anticoagulation medications before the washout period, per the package insert, and at the physician's discretion;
• Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the area to be treated, personal history of melanoma;
• Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
• Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
• Tattoos in the treatment areas;
• Dysplastic nevi in the treatment areas;
• Participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria;
• Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (1)

Laser & Skin Surgery Medical Group Inc

Sacramento, California, 95816, United States

Location

Results Point of Contact

• Title: Suzanne Kilmer, MD
• Organization: Laser & Skin Surgery Medical Group Inc.

Study@skinlasers.com

916-456-0400

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: January 9, 2011
• First Posted: January 25, 2011
• Study Start: June 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 21, 2016
• Results First Posted: April 3, 2014

Record last verified: 2014-01

Locations

US (1)