Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lumenis Ltd.
ClinicalTrials.gov Identifier:
NCT01282866
First received: January 9, 2011
Last updated: February 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Hair Removal
Device: LightSheer Duet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece

Further study details as provided by Lumenis Ltd.:

Primary Outcome Measures:
  • Hair Count [ Time Frame: 6 month following last treatment ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Treatment Time [ Time Frame: Each treatment ] [ Designated as safety issue: No ]
    The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.

  • Level of Comfort Associated With Treatment [ Time Frame: Each treatment ] [ Designated as safety issue: No ]
  • Hair Count [ Time Frame: 15 month following last treatment ] [ Designated as safety issue: No ]

    The hair at the treatment area is counted at Baseline and 15 months following the last treatment.

    Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline.



Enrollment: 35
Study Start Date: June 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HS treatment
Treatment with HS handpiece
Device: LightSheer Duet
LightSheer Duet HS handpiece

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult, female, 18 years of age or older with skin type I-IV;
  2. Having at least one suitable treatment area for hair removal with brown hair;
  3. Able and willing to comply with the treatment/follow-up schedule and requirements;
  4. Able to read, understand and provide written Informed Consent.
  5. 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.

Exclusion Criteria:

  1. Showing symptoms of hormonal disorders, as per the Investigator's discretion;
  2. Use of oral isotretinoin (Accutane®) within 6 months
  3. Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
  4. History of keloid formation or poor wound healing in a previously injured skin area;
  5. Significant skin conditions affecting treated area or inflammatory skin conditions;
  6. Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
  7. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
  8. Having a history of bleeding disorder or taking anticoagulation medications before the washout period, per the package insert, and at the physician's discretion;
  9. 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;
  10. Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
  11. Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
  12. Tattoos in the treatment areas;
  13. Dysplastic nevi in the treatment areas;
  14. 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;
  15. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
  16. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study;
  17. Allergy or history of an allergy to any topical anesthetic used;
  18. Pregnant, expectation of pregnancy, postpartum (<3 months) or nursing (<6 weeks);
  19. History of livedo reticularis, an autoimmune vascular disease;
  20. Hypersensitivity at the treatment site to any agents, solutions, or gel used in the treatment (applies to ET handpiece only), if no alternative exists;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282866

Locations
United States, California
Laser & Skin Surgery Medical Group Inc
Sacramento, California, United States, 95816
Sponsors and Collaborators
Lumenis Ltd.
  More Information

No publications provided

Responsible Party: Lumenis Ltd.
ClinicalTrials.gov Identifier: NCT01282866     History of Changes
Other Study ID Numbers: LUM- ABU-LSDuet-08-001
Study First Received: January 9, 2011
Results First Received: January 6, 2014
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 20, 2014