Comparison of Efficacy, Safety and Tolerability of Two Different 810 nm Diode Lasers for Hair Reduction
Condition: Hypertrichosis
MeSH terms: Hypertrichosis
Intervention: Soprano/SHR; LightSheer
Intervention description: 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.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hair removal; Laser; Diode laser

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.
    

Eligibility 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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