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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christopher Zachary, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01212172
First received: September 22, 2010
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Hair Removal
Device: Soprano/SHR
Device: LightSheer
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Reduction in hair growth [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Photographic hair count at baseline, and at 1, 6, 12 months following last (5th laser treatment)


Secondary Outcome Measures:
  • Reduction in hair density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Photographic imaging of hair density at 1, 6, 12 months following last (5th) laser treatment.

  • Hair follicle histology [ Time Frame: Skin biopsy of treatment area taken at 24 hr after the. 1st and 5th treatment. ] [ Designated as safety issue: No ]
    Skin biopsy of treatment area taken at 24 hr after the 1st and 5th treatment in two subjects receiving .with the Alma laser


Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01212172

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

Additional Information:
No publications provided

Responsible Party: Christopher Zachary, MBBS, FRCP, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01212172     History of Changes
Other Study ID Numbers: 2010-7704
Study First Received: September 22, 2010
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Hair removal
Laser
Diode laser

ClinicalTrials.gov processed this record on July 24, 2014