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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertrichosis
• Intervention / Treatment: Device: Soprano/SHR; Device: LightSheer

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • Department of Dermatology Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Soprano/SHR; Alma Soprano/SHR 810 nm Diode Laser	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.; Other Names: Soprano/SHR laser
Active Comparator: LightSheer; LightSheer Duet 810 nm diode laser	Device: 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.; Other Names: Duet LightSheer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Christopher B Zachary, MBBS, FRCP, University of California, Irvine

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 22, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 30, 2010

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Diode laser; Laser; Hair removal
• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Hypertrichosis
• Other Study ID Numbers: 2010-7704