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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01282866
Other study ID # LUM- ABU-LSDuet-08-001
Secondary ID
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


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
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