Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece

Hair Removal Clinical Trial

Official title:

Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282866
• Other study ID #: LUM- ABU-LSDuet-08-001
• Status: Completed
• Phase: N/A
• First received: January 9, 2011
• Last updated: February 20, 2014
• Start date: June 2009
• Est. completion date: November 2011

Study information

• Verified date: January 2014
• Source: Lumenis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hair Removal

Intervention

Device:
• LightSheer Duet
LightSheer Duet HS handpiece

Locations

Country	Name	City	State
United States	Laser & Skin Surgery Medical Group Inc	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Lumenis Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Treatment Time	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.	Each treatment	No
Secondary	Level of Comfort Associated With Treatment		Each treatment	No
Secondary	Hair Count	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.	15 month following last treatment	No