Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

NCT01801202 | Completed

• 1 other identifier: LUM-ABU-HS 805nm-12-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

• The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction.
• Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.
• Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.

Conditions

Hair Removal

Outcome Measures

Primary Outcomes (2)

• Number of subjects with Adverse Events

  To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece

  1 year

• Hair count

  To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece

  6 monts follow up

Secondary Outcomes (2)

• Subject's comfort using VAS

  Baseline, 4, 8, 12, 16 weeks;

• Asses subject's perception of improvement and satisfaction

  8, 16 weeks following baseline; 3 and 6 monts follow up

Study Arms (1)

Hair removal

EXPERIMENTAL

hair removal treatment using 805nm LightSheer Duet HS handpiece

Device: LightSheer Duet HS handpiece

Interventions

LightSheer Duet HS handpiece DEVICE

The approach to be studied here relies on a cleared modality, the LightSheer Duet High Speed (HS) that uses 805 nm diode laser with vacuum (K053628).

Hair removal

Eligibility Criteria

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

You may qualify if:

• Able to read, understand and provide written Informed Consent;
• Healthy adult, male or female, 18 years of age or older with skin type I-IV;
• Having a suitable treatment area for hair removal;
• Able and willing to comply with the treatment/follow-up schedule and requirements;
• Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.

You may not qualify if:

• Pregnant, expectation of pregnancy, postpartum or nursing (\<6 months);
• Hormonal disorders that may affect hair growth;
• Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
• Livedo reticularis;
• Uncontrolled systemic diseases such as diabetes;
• Active infections in the treated area;
• Dysplastic nevi;
• Significant concurrent skin conditions or any inflammatory skin conditions;
• Active cold sores, open lacerations or abrasions;
• Chronic or cutaneous viral, fungal, or bacterial diseases;
• Current cancer;
• History of skin cancer or pre-cancerous lesions at the treatment areas;
• Use of Accutane™ (Isotretinoin) within the past six month;
• Keloid formation in the treatment area;
• Tattoos in the treatment area;

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (1)

Laser & Skin Surgery Medical Group Inc

Sacramento, California, 95816, United States

Location

Study Officials

• Suzanne Kilmer, MD

  Laser & Skin Surgery Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

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: February 21, 2013
• First Posted: February 28, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2014-08

Locations

US (1)