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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212172
Recruitment Status : Completed
First Posted : September 30, 2010
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Information provided by (Responsible Party):
Christopher Zachary, University of California, Irvine

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertrichosis Device: Soprano/SHR Device: LightSheer Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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 Name: 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 Name: Duet LightSheer

Primary Outcome Measures :
  1. Change in Hair Growth [ Time Frame: 1 month, 6 month, 12 month ]
    % reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment]

Secondary Outcome Measures :
  1. Pain Rating Scale [ Time Frame: 12 months ]
    Pain during each treatment was measured subjectively by patients on a 0-10 visual analogue scale (0=no pain, 10=unbearable pain).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01212172

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United States, California
Department of Dermatology Clinical Research
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
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Principal Investigator: Christopher B Zachary, MBBS, FRCP University of California, Irvine

Additional Information:
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Responsible Party: Christopher Zachary, MBBS, FRCP, University of California, Irvine Identifier: NCT01212172     History of Changes
Other Study ID Numbers: 2010-7704
First Posted: September 30, 2010    Key Record Dates
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016
Last Verified: October 2015
Keywords provided by Christopher Zachary, University of California, Irvine:
Hair removal
Diode laser
Additional relevant MeSH terms:
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Hair Diseases
Skin Diseases