Clinical Evaluation of Hair Removal and Permanent Hair Reduction for Skin Types VI Using Intense Pulsed Light

Study Overview
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Brief Summary
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This is a Multi-center, blinded, baseline-controlled, prospective study to evaluate permanent hair reduction and removal for skin types V and VI using IPL.

Detailed Description
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One hundred and twenty (120) subjects who are Fitzpatrick Skin Type V-VI, and have a suitable treatment area for hair removal will be evaluated in this study. Each subject will receive six treatments at four to six week intervals upon re-growth of hair and return for follow-up visits at one, three and six months after the last treatment. Measurement Equipment Standard High Resolution Digital Camera Labels for hair count Customized hair count sticker templates will be placed directly on the skin and the hairs in this window will be counted at specific visits during the study as detailed in section. Study Procedures Each subject will participate in the study for a period of at least 11 months. The study is anticipated to be completed within twelve months. Test spots Up to 3 test spots will be performed in the selected treatment area to determine the optimal parameters / setting. Treatment The treatment areas are divided into 3 groups. Each Subjects will be allocated to one of the following groups:: Two small anatomical areas (right and left axillae and double sided bikini line) or; One double sided large area (right and left thighs) or; One large area (whole back / abdomen) Based on the mild nature of treatment, anesthesia is not required. Before starting treatment apply a layer of conductive gel to the treatment area. After applying the conductive gel, locate the applicator in close contact, perpendicular to the skin with no pressure applied. Pressing the applicator will fire the IPL pulse. In order to ensure full coverage of the treatment area applicator placement should overlap approximately 1/3 of the previously treated skin. Post-treatment Instructions Cold packs may be placed on the treated area for post treatment cooling. Subjects should be aware that post treatment erythema, edema and some discomfort of the treated areas are possible and should not be a cause for concern. They may also experience some purpura in the treated areas which would be expected to resolve within several days.

Official Title
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Clinical Evaluation of Hair Removal and Permanent Hair Reduction for Skin Types V-VI Using Intense Pulsed Light

Conditions
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Removal of Excess or Unwanted Body Hair

Intervention / Treatment
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* Device: Treatment group
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read, understand and provide written Informed Consent; Subject has black or dark brown terminal hairs in the areas to be treated. Terminal hair density requirement of greater than 15 hairs within the hair count site (3x3 cm area) as determined by manual hair count performed by the study investigator. Healthy adult, male or female, 21 years of age or older with skin type V-VI; Having a suitable treatment area for hair removal; Able and willing to comply with the treatment/follow-up schedule and requirements; Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study. Exclusion Criteria: Subject has light ,gray terminal or fine hairs in all/some parts of the treated area; Pregnant, expectation of pregnancy, postpartum or nursing (<6 months); Hormonal disorders that may affect hair growth; Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications; Livedo reticularis; Uncontrolled systemic diseases such as diabetes; Active infections in the treated area; Dysplastic nevi; Significant concurrent skin conditions or any inflammatory skin conditions; Active cold sores, open lacerations or abrasions; Chronic or cutaneous viral, fungal, or bacterial diseases; Current cancer; History of skin cancer or pre-cancerous lesions at the treatment areas; Use of Accutane™ (Isotretinoin) within the past six month; Keloid or Hypertrophic scar formation in the treatment area; Tattoos in the treatment area; Bleeding coagulopathies or use of anticoagulants; Auto-immune disorders; Erythema abigne, 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, herbal supplements, perfumes or cosmetics that may affect sensitivity to light; Poor wound healing; Sunburns; Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a month) and during the course of the evaluation; Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Hair removal treatment using Venus Versa IPL energy | Device: Treatment group<br>* The intense pulsed light (IPL) applicator with a wavelength of 690 nm and spot size (treatment area) of 30 mm by 10 mm will be used to deliver the energy to the treatment area.<br>Other: No intervention<br>* Subject will act as their own control where the baseline hair count will be used as a comparator to the hair count after treatment.<br>|
| Placebo Comparator: No intervention<br>Subject hair count at baseline will act as the control to which the hair count at 6 months after the last treatment. | Other: No intervention<br>* Subject will act as their own control where the baseline hair count will be used as a comparator to the hair count after treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Count 6 Months Following Last Treatment | Hair count reduction in marked treatment area assessed from photographs taken 6 months following the last treatment as compared to photographs of the marked treatment area taken at baseline. | 6 months after last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hair removal, depilation, epilation