Sunstone IPL (Intense Pulsed Light) for Hair Reduction

Completed · Not applicable

Conditions studied: Hair Removal

In brief

This is a prospective, multi-center, single-arm, single blinded study to evaluate the safety and efficacy of the Sunstone IPL (Intense Pulsed Light) device to remove hair.

Key facts

Study ID

NCT03921814

Run by

Philips Healthcare

People needed

102

Starts

2019-04-11

Expected to finish

2022-05-20

Last updated by the study team

2022-10-20

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Sera Collection — Montebello, California, United States
• Sadick Research Group — New York, New York, United States

Full record on ClinicalTrials.gov

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