Clinical Investigation of Safety and Effectiveness of Emerald IPLdevice

Completed · Not applicable

Conditions studied: Hair Removal

In brief

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 Emerald IPL-device will be investigated for treatment in face of subjects with ST I - IV and for treatment in face, axilla, bikini area, and legs of subjects with ST V. In-clinic, the study subjects will undergo twelve IPL-treatments bilaterally at the qualified areas (face and / or axilla, bikini line, and legs) with the Emerald IPL device applied by a device operator. Hair re-growth in each area will be evaluated separately and across all skin types. After the 4 bi-weekly treatments, one follow-up visit will be organized two weeks after the 4th treatment. After the completion of the 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).

Key facts

Study ID

NCT03945383

Run by

Philips Healthcare

People needed

120

Starts

2019-04-15

Expected to finish

2022-01-14

Last updated by the study team

2022-10-19

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
• Are healthy female subjects, in age of 18-65 years
• Have natural body hair color that is dark blonde, brown or black in the designated treatment areas
• 1. Subjects of ST I-IV - Face group:
• 1.1 Have Fitzpatrick Skin Type I, II, III, or IV
• 1.2 Measure melanin value ≤ 375 in the qualifying treatment areas bilateral on upper lip (face)
• 1.3. Have a minimum of 10 hairs in the 1x2cm2 qualifying treatment areas bilateral on upper lip (face), by visual inspection
• 2. Subjects of ST V - All body area group:
• 2.1. Have Fitzpatrick Skin Type V
• 2.2. Measure melanin value ≤ 553 in the qualifying treatment areas bilateral on upper lip (face), axilla, bikini line, and leg
• 2.3. Have a minimum of 10 hairs in the 1x2cm2 qualifying treatment areas bilateral on upper lip (face), by visual inspection
• 2.4.Have a minimum of 24 hairs in each of the 2x4cm2 qualifying treatment areas bilateral on axilla, bikini line, and leg, by visual inspection
• 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 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 axilla, bikini line, leg, and face
• 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 natural body hair color that is white, light blond, or red in the designated treatment areas
• 1. Subjects of ST I to IV - Face group:
• 1.1. Have Fitzpatrick Skin Type V or VI
• 1.2. Measure melanin value higher than 375 in the qualifying treatment areas bilateral on upper lip
• 1.3. Have fewer than 2 qualifying treatment areas on bilateral on upper lip (face)
• 2. Subjects of ST V - All body area group:
• 2.1. Have Fitzpatrick Skin Type I, II, III, IV, or VI
• 2.2. Measure melanin value higher than 553 in any of the qualifying treatment areas bilateral on the body
• 2.3. Have fewer than 8 qualifying treatment areas bilateral: 2 in face, 2 in axilla, 2 on bikini line, and 2 on legs
• Have a malignant or pre-malignant pigment 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 be 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 NSAIDs 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 a anticoagulative medication or thromboembolic condition
• Have taken 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 in the areas to be treated within 6 months prior to treatment
• Have been exposed to strong sunlight or an artificial tanning machine in the area to be treated within 4 weeks of enrolment
• Have a tattoo(s), warts, moles, benign skin lesions, dark pigmented areas, permanent make-up etc. in the areas to be treated.
• Have eczema, psoriasis, lesions, open wounds or any skin affliction in the areas to be treated
• Have a history of keloid scar formation
• Have a history of herpes outbreaks in the areas to be treated

Where it is running

• My Community Research Center — Miami, Florida, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• Virginia Clinical Research — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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