Clinical trial NCT00657085: Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction
Official title: Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laser Hair Removal
Keywords: Laser hair removal
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5 Adult male subjects that have sought laser back hair removal

Brief summary: To observe the qualitative comparison of follicular damage between treatment with the LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy.


Eligibility criteria: Inclusion Criteria:

1. Healthy male adult, 18 years of age or older with skin type I-V;
2. Having a suitable treatment area for hair removal with brown or black hair (no gray);
3. Able and willing to comply with the treatment/follow-up schedule and requirements;
4. Able to read, understand and provide written Informed Consent.

Exclusion Criteria:

1. Showing symptoms of hormonal disorders, as per the Investigator's discretion;
2. Use of oral isotretinoin (Accutane®) within 6 months, or off label use of topical isotretinoin in immediate treated area or in its proximity within 3 months, of study enrollment or during the course of the study;
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. Adverse reaction to the treatment gel to be used in the evaluation;
5. History of keloid formation or poor wound healing in a previously injured skin area;
6. Significant skin conditions affecting treated area or inflammatory skin conditions;
7. Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
9. Having a bleeding disorder or taking anticoagulation medications within the preceding 6 months;
10. 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;
11. Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
12. Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
13. Photosensitivity disorder that can be exacerbated by infrared light;
14. Tattoos in the treatment areas;
15. Dysplastic nevi in the treatment areas;
16. Allergy or history of an allergy to the topical anesthetic used.
17. Participation in a study of another device or drug within 3 months 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;
18. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
19. 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.

Primary outcomes:
measure: Follicular damage assessed by histology
timeFrame: first visit
Secondary outcomes:
measure: Comparison of permanent hair reduction between ET and HS handpieces
timeFrame: 2 month follow up visit
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Seaver Soon
state: California
Study officials:
affiliation: Scripps Dermatology
name: Seaver Soon, MD
role: PRINCIPAL_INVESTIGATOR
References: