Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction

Hypertrichosis Clinical Trial

Official title:

Side-by-Side Comparison of 810 nm Diode Laser Technology With Low Fluence-High Repetition Rate vs Low Fluence-Vacuum Assist - A Split - Extremity Efficacy , Safety and Tolerability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212172
• Other study ID #: 2010-7704
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2010
• Last updated: January 7, 2016
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: October 2015
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to compare two different 810 diode laser systems (Soprano XL (SHR Mode)and Light Sheer Duet) for laser hair removal. The goal is to determine if each laser system is effective at reducing the amount of hair on the lower legs or the axilla (arm pit). Another goal is determine the subject's perspective on the treatment including tolerability and effectiveness.

Description:

This side-by-side split body, blinded, randomized single-center study is comparing two different 810 nm diode laser technologies for the purpose of permanent hair reduction to determine the effectiveness and subject's tolerance for hair reduction. Twenty volunteers will be enrolled into this study. Subjects will receive a total of 5 treatments of either axilla or lower legs. 10 patients will have both axilla treated while the other 10 subjects will have the lower legs treated. Placement to the axilla treatment group vs. the lower leg treatment group is random.

Treatment areas will be randomized to receive Soprano SHR treatment or Light Sheer/Duet treatment. One extremity (example: right axilla) will receive Soprano SHR treatment and the contra-lateral extremity (example: left axilla) will receive Duet treatment. The treatments will occur every 6 - 8 weeks and then there will be follow up visits at 1 month, 6 months, and 12 months after the last treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects must be at least 18 years of age.

2. Subjects must be in reasonably good health as defined by the Investigator.

3. Subject agrees to avoid tanning during their participation in this trial.

4. Subject has Fitzpatrick skin types I-V and dark brown hair.

5. Subjects must agree to avoid shaving legs less than 72 hours prior to a study visit.

6. Subjects have indicated willingness to participate in the study by signing an informed consent document.

Exclusion Criteria:

1. Subject is pregnant, lactating, or planning to get pregnant within the study period.

2. Subject is unwilling to use birth control during the study period if of child bearing age.

3. Subject has a known history of photosensitivity or use of medication with photosensitizing properties.

4. Subject has skin disease on exam at screening.

5. Subject has history or evidence of any chronic or reoccurring skin disease or disorder(e.g., psoriasis, Netherton syndrome, etc.) affecting the treatment area.

6. Subject has a history of keloid or hypertrophic scar formation.

7. Subject has a tattoo in the treatment area.

8. Subject has been tanning within the past 30 days.

9. Subject has history of confounding cancerous or pre-cancerous skin lesions in the treatment area.

10. Subject has used prohibited therapies (electrolysis, threading, waxing, depilatory), prohibited oral prescription medications (isotretinoin, steroids), or prohibited topical meds (steroids) on the treatment area within 30 days prior to enrollment.

11. Subject is unwilling to discontinue use of above listed prohibitive therapies for the duration of treatment.

12. Subject has a history of laser hair removal in the treatment area.

13. Subject has participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past 30 days.

14. The investigator feels that for any reason the subject is not eligible to participate in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrichosis

Intervention

Device:
• Soprano/SHR
For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time.
• LightSheer
The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings.

Locations

Country	Name	City	State
United States	Department of Dermatology Clinical Research	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hair Growth	% reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment]	1 month, 6 month, 12 month	No
Secondary	Pain Rating Scale	Pain during each treatment was measured subjectively by patients on a 0-10 visual analogue scale (0=no pain, 10=unbearable pain).	12 months	No

External Links

•   UC Irvine Department of Dermatology Clinical Research