Sunstone IPL (Intense Pulsed Light) for Hair Reduction

Exclusion Criteria

• •1. Have fewer than 8 qualifying treatment areas: 2 in face (upper lip), 2 in axilla, 2 on bikini line, 2 on leg)
• •2. Have a malignant or pre-malignant pigmented lesion in the area to be treated
• •3. Have scarring or infection of the area to be treated
• •4. Have a known history of photosensitivity or use of medication known to induce photosensitivity
• •5. Are currently pregnant or lactating or planning to become pregnant in the period of the study, per subject report
• •6. Are currently on a daily dose of aspirin or NSAIDS (e.g. acetaminophen, ibuprofen, etc.) or have taken aspirin and/or NSAID within 5 days prior to treatment that would reduce or increase the sensation of pain
• •7. Are not willing to abstain from the use of products or light exposure that would induce tanning in the treatment areas during the IPL treatment period (first 10 months)
• •8. Have a history of immunosuppressive disease (including HIV infection or AIDS)
• •9. Are on anticoagulative medication or have thromboembolic condition
• •10. Any form of isotretinoin (such as Accutane or Roaccutane etc.) in the last six months.
• •11. Have an active implantable device such as a pacemaker, neurostimulator or internal defibrillator
• •12. Have used waxing or other methods of root hair removal, or photo-epilation within 6 months prior to treatment
• •13. Have been exposed to strong sunlight or an artificial tanning machine within 4 weeks of enrolment
• •14. Have a tattoo(s), warts, moles, benign skin lesions, dark pigmented areas, permanent make-up etc. in the treatment areas.
• •15. Have eczema, psoriasis, lesions, open wounds or any skin affliction in the treatment areas
• •16. Have a history of keloid scar formation
• •17. Have a history of herpes outbreaks in the designated treatment areas
• •18. Have a history of photosensitive epilepsy
• •19. Have a condition related to hormonal changes like polycystic ovarian syndrome (PCOS) or taking drugs leading to hormonal changes resulting in excessive hair growth like hirsutism and idiopathic hirsutism
• •20. Have diabetes, or metabolic disease that affects hair growth
• •21. Taking immunosuppressive medication(s)
• •22. Have a disease related to photosensitivity, such as polymorphic light eruption (PMLE), solar urticaria, porphyria etc.
• •23. Have a history of skin cancer, including past basal cell carcinoma and/or squamous cell carcinoma in the designated treatment areas
• •24. Have a history of any radiation therapy in any of the designated treatment areas
• •25. Have a history of radiation therapy in non-treatment areas within 5 years
• •26. Have a history of chemotherapy
• •27. Have used hair growth inhibitors and/or accelerators within 6 months preceding enrolment
• •28. Have had laser or electrolysis treatment for the removal of hair in the treatment sites within the last year
• •29. Have natural body hair colors of white, grey, light to mid-blond, or red in the designated treatment areas
• •30. Have bleaching of the body hair in the designated treatment areas 6 months prior to study enrolment
• •31. Have shaved treatment areas within 7 days prior to study enrolment
• •32. Participating in other clinical studies prior to, or concurrently with this study, that could be deemed to interfere with full and complete participation in this study - as determined by the site Investigator.
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