Laser Hair Removal Study

The Laser and Skin Surgery Center is recruiting subjects with skin type I-IV to participate in a clinical research study for Laser Hair Removal.

STUDY DESIGN

This is a clinical study to evaluate the safety of hair removal and to verify if hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm new handpiece occurs. A minimum of 20 participants will be enrolled in this study.

Participants that meet the inclusion criteria will be enrolled to the study and attend initial screening visit to determine eligibility and review their medical history. Participants will receive 5 treatments (4-6 weeks apart) with the study device and return for 2 follow-up visits (3 and 6 months after last treatment) to verify if hair removal and permanent hair reduction occurred.

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be entered into the study:

  • Able to read, understand and provide written Informed Consent;
  • Healthy adult, male or female, 18 years of age or older with skin type I-IV;
  • Having at least one suitable treatment area for hair removal (right and left axillae and double sided bikini line or; right
    and left thighs I shins I arms or; whole back I abdomen and chest);
  • Able and willing to comply with the treatment/follow-up schedule and requirements;
  • Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to enrollment and throughout the course of the study.

Exclusion Criteria:

Any of the following will exclude the subject from the stugy:

  • Pregnant. expectation of pregnancy, postpartum or nursing (6 months);
  • Hormonal disorders that may affect hair growth;
  • Immunosuppressive diseases, including AIDS and HtV infection, or use of immunosuppressive medicines.
  • Purplish discoloration of the skin (Livedo reticularis);
  • Uncontrolled systemic diseases such as diabetes;
  • Active infections in the treated area;
  • Atypical moles (Dysplastic nevi);
  • Significant concurrent skin conditions or any inflammatory skin conditions such as Dermatitis, Eczema Sebaceous cysts;
  • Active cold sores, open lacerations or abrasions;
  • Chronic or cutaneous viral, fungal, or bacterial diseases, such as Rubella, Skin Fungal Infections, or Plaque;
  • Current cancer;
  • History of skin cancer or pre-cancerous lesions at the treatment areas;
  • Use of Accutane™ (Isotretinoin) within the past 6 month;
  • Scar formation in the treatment area;
  • Tattoos in the treatment area;
  • Bleeding coagulopathies, such as hemophilia and Von Willebrand’s disease, or use of anticoagulants (e.g. Coumadin, Heparin, Phenindione; Atromentin)
  • Auto-immune disorders such as Rheumatoid arthritis, Psoriasis;
  • Red skin rash caused by overexposure to heat (Erythema ab igne) – when identified treatments should be discontinued;
  • Photosensitivity disorder that can be exacerbated by laser or intense light;
  • Herpes simplex in the treatment area;
  • Use of medications (e.g. antibiotics, diuretics, anti-fungal medications, antihistamines, and drugs used to treat seizures, herbal supplements (e.g. Sf. John’s wort). perfumes or cosmetics that may affect sensitivity to light (fragranced cosmetic products that contain furocoumarins – chemicals that absorb U.V);
  • Poor wound healing;
  • Sunburns;
  • Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a week) and during the course of the study;
  • Prior skin treatment with laser or other devices on the same treated areas within the last 6 months prior to study enrollment or during the course of the study.

If you feel that you meet the qualifications please respond via email: study@skinlasers.com

ENROLLMENT: CLOSED FOR ENROLLMENT.

Please contact Julie, our Study Coordinator, via email only. Study Email: study@skinlasers.com