Sunstone IPL (Intense Pulsed Light) for Hair Reduction

Prospective, multi-center, single-arm, single blinded (Philips hair counter) study in healthy women of skin types I up to and including V.

Safety and efficacy of hair removal with the Investigational Philips IPL-device will be investigated.

In-clinic, each study subject will undergo twelve IPL-treatments at four areas bilaterally (face, axilla, bikini line, and legs) with an investigational IPL device applied by a device operator.

Hair re-growth in four body areas, face, axillae, bikini line and leg will be evaluated separately.

After the 4 bi-weekly treatments, one follow-up visit will be organized. After the completion of full treatment cycle (12 treatments), subjects will be followed for 1 and 3 months (short-term follow-up) and for 6, 9 and 12 months (long-term follow up).

Inclusion criteria

• Be willing to provide informed consent
• Have a minimum of 24 hairs in each of the 2x4cm2 treatment area in axilla, bikini line, and leg, by visual inspection
• Have a minimum of 10 hairs in the 1x2cm2 treatment area in face (upper lip), by visual inspection
• Have a Fitzpatrick Skin Type I to V, with a melanin index less or equal to 553, as measured by Mexameter MX 18 in the designated treatment areas on face, axilla, bikini, and legs
• Have natural body hair color that is dark blonde to black in the designated treatment areas
• Are female subjects 18-65 years of age
• Be either post-menopausal or surgically sterilized, or using a medically acceptable form of birth control (e.g., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence, etc.).
• Be willing to participate in all scheduled study visits
• Be willing to refrain from deliberate exposure to strong sun, products or procedures that would cause the skin to become darker in the designated treatment areas during the treatment phase
• Be willing to refrain from the use of hair growth inhibitors/accelerators during the course of the study
• Be willing to refrain from waxing, depilating or epilating of the face (upper lip), axilla, bikini line, and leg during the course of the study
• Be willing to refrain from using aspirin or NSAIDS (e.g. acetaminophen, ibuprofen, etc.) within 5 days prior to and 5 days after treatment(s)

Exclusion criteria

• Have fewer than 8 qualifying treatment areas: 2 in face (upper lip), 2 in axilla, 2 on bikini line, 2 on leg)
• Have a malignant or pre-malignant pigmented lesion in the area to be treated
• Have scarring or infection of the area to be treated
• Have a known history of photosensitivity or use of medication known to induce photosensitivity
• Are currently pregnant or lactating or planning to become pregnant in the period of the study, per subject report
• 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
• 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)
• Have a history of immunosuppressive disease (including HIV infection or AIDS)
• Are on anticoagulative medication or have thromboembolic condition
• Any form of isotretinoin (such as Accutane or Roaccutane etc.) in the last six months.
• Have an active implantable device such as a pacemaker, neurostimulator or internal defibrillator
• Have used waxing or other methods of root hair removal, or photo-epilation within 6 months prior to treatment
• Have been exposed to strong sunlight or an artificial tanning machine within 4 weeks of enrolment
• Have a tattoo(s), warts, moles, benign skin lesions, dark pigmented areas, permanent make-up etc. in the treatment areas.
• Have eczema, psoriasis, lesions, open wounds or any skin affliction in the treatment areas
• Have a history of keloid scar formation
• Have a history of herpes outbreaks in the designated treatment areas
• Have a history of photosensitive epilepsy
• 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
• Have diabetes, or metabolic disease that affects hair growth
• Taking immunosuppressive medication(s)
• Have a disease related to photosensitivity, such as polymorphic light eruption (PMLE), solar urticaria, porphyria etc.
• Have a history of skin cancer, including past basal cell carcinoma and/or squamous cell carcinoma in the designated treatment areas
• Have a history of any radiation therapy in any of the designated treatment areas
• Have a history of radiation therapy in non-treatment areas within 5 years
• Have a history of chemotherapy
• Have used hair growth inhibitors and/or accelerators within 6 months preceding enrolment
• Have had laser or electrolysis treatment for the removal of hair in the treatment sites within the last year
• Have natural body hair colors of white, grey, light to mid-blond, or red in the designated treatment areas
• Have bleaching of the body hair in the designated treatment areas 6 months prior to study enrolment
• Have shaved treatment areas within 7 days prior to study enrolment
• 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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