![]() The device can only be “fired” when the hand piece is in direct contact with the skin surface. The specifications for the device include wavelengths of light from 475 to 1200nm, a maximum energy density of 5J/cm 2, a spot size of 20x30mm 2, and a pulse rate of one pulse every 3.5 seconds. The traditional term, IPL, has been put aside for this handheld device, and instead is referred to as HPL (home pulsed light). The Silk'N home hair removal device is a small, portable, low-energy IPL. The device utilized was the Silk'N (Home Skinovations, Kfar Saba, Israel) ( Figure 1). Once all of the inclusion and exclusion criteria were determined and the informed consent executed, the initial treatment was performed by trained staff, as the subject observed. Some of the potential adverse events included pain, skin redness (erythema), swelling (edema), damage to natural skin texture (crust, blister, or burn), changes of pigmentation (hyper- and hypopigmentation), scarring, fragile skin, and bruising. ![]() Any use on the face was strictly prohibited during the clinical trial period.Īll possible risks and potential adverse events that have been recorded from the use of IPLs and other laser systems for hair removal were discussed in length during the consent process. Also, patients were excluded if they waxed or used any other forms of photoepilation in the treatment areas for the three months prior to the treatment session.ĭuring discussions and visits with the subjects, the clinicians continuously reiterated that this device is not recommended for use on the face. ![]() Inclusion criteria included having unwanted hairs on the body (legs, arms, bikini area, or axilla) having Fitzpatrick skin types I–IV avoiding pregnancy during the study (postmenopausal, surgically sterile, or using a medically acceptable form of birth control, which included oral contraceptives, intrauterine devices, contraceptive implant, barrier methods with spermicide, or abstinence) and having the willingness to follow the treatment care and post-treatment schedule.Įxclusion criteria included having premalignant or malignant pigmented lesions in the treatment areas, a previous history of scarring or previous skin infection in the area to be treated, known photosensitivity to light, pregnancy, a history of either Type I or II diabetes mellitus, sunburn or recent exposure in the area to be treated, taking medication known to induce photosensitivity, taking anticoagulation medications or having a history of thrombolembolic conditions, having a pacemaker or internal defibrillator, and taking NSAIDs two weeks before and two weeks after the treatment. All of the participants had to meet predetermined inclusion and exclusion criteria for admittance into the trial. All of the study participants reviewed and signed an IRB-approved informed consent form (ICF) prior to the beginning of the trial. The patients varied in age from 23 to 60 years of age. Twenty-two female patients were enrolled in this clinical trial, with 20 completing the trial. The secondary objective of this institutional review board (IRB)-approved clinical trial was to verify previously reported clinical trials of the same device. With this in mind, a clinical trial was designed with the primary objective to assess safety and efficacy of a low-energy IPL specifically designed for home use. Over the years, there have been numerous reports on the safety and efficacy of IPLs for hair removal, which pointed to the IPL as a suitable application to develop for home hair removal. 5– 7Īs the industry, including established laser companies, began to develop at-home devices for epilation, market research provided a financial projection of billions of dollars annually. ![]() 4 Other investigators verified these results. Clinical results of the IPL for hair removal on darker skin types were also published, showing that with appropriate cut-off filters, the IPL can be used successfully in all skin types. 1– 3 These studies proved that an IPL is a legitimate and useful light source for effective hair removal. The first IPL dedicated solely for hair removal was appropriately researched and the findings published on its safety and efficacy following a single treatment, as well as long-term safety and efficacy with one- and two-year results. The use of intense pulsed light (IPL) for hair removal dates back well over 15 years. If these devices are to receive any merit, then it is the dermatologist's obligation to assess the safety and efficacy of them, as with any device in the research setting. Whether you agree with the notion of using at-home devices for epilation or not, there can be no mistake that there are a myriad of these devices available. ![]()
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