Abstract
Acne vulgaris, despite being one of the most common dermatological diseases, remains challenging to treat. Acne lesion location and type, skin tone, genetics, and environmental factors influence mono- or multimodal therapeutic decisions. Combination topical and oral treatments may successfully reduce lesion count; however, these agents take time to work, and side effects are not uncommon. The long-term therapeutic engagement required to treat acne may be too costly or burdensome for many patients, which may impact treatment adherence, which can negatively impact patient outcomes. There is increased interest in noninvasive acne treatments to reduce side effects, provide rapid results, and foster treatment adherence. TheraClearX® X Acne System combines broadband pulsed light and vacuum suction technology. The combination of these two treatment modalities mechanically clears congested follicles and targets endogenous porphyrins produced by Cutibacterium acnes and other acnegenic bacteria. This article describes the proposed mechanism of action, treatment advantages, examples of treatment protocols, and anecdotal results using this combination device in the treatment of acne.
Keywords: Acne, vacuum, broadband light, noninvasive
BRIEF OVERVIEW OF ACNE TREATMENT DEVICES
Pulsed light treatments (IPLs). IPLs have been used both alone and in combination with other modalities to rapidly reduce active acne.1–4 Postulating that a broadband light source would activate endogenous porphyrins, researchers have assessed the use of pulsed light and heat devices in the treatment of acne, reporting noticeable improvements in acne lesions.5,6 Chang et al7 evaluated a pulsed light device with a cut-off filter between 530 and 750nm in the treatment of inflammatory acne and post-acne-related erythematous lesions. Patients were randomized to a split-face treatment, using benzoyl peroxide as the control. Results showed a decrease in lesion count on both sides of the face, with no statistical difference; however, the pulsed light-treated side was noted to have marked improvement in acne- related sequelae, such as post-inflammatory erythema and hyperpigmentation.8
Vacuum. The use of vacuum suction for the treatment of acne was first described in dermatology literature by Moschowitz,9 who described eight patients with acne who were treated with a rubber bulb to apply slight suction to acne lesions so as to cause localized hyperemia.
Combination pulsed light and vacuum. A combination of pulsed light and vacuum has been evaluated in the treatment of acne. In a multicenter retrospective study, Shamban et al10 assessed the effectiveness of a combination of pulsed light and vacuum device, reporting physician-evaluated mean clearance rates of 50 percent (following a single treatment) to 90 percent (following four treatments) in patients with mild-to-severe acne.
Based on performing over 150 acne treatments using a combination pulsed light and vacuum device, the current author has observed that marked improvement in acne lesions can be achieved in as few as two treatments spaced 1 to 2 weeks apart.
Corroborating this, Gold et al11 administered four treatments using a pulsed light and vacuum device to patients with acne at three-week intervals. At 91 days (1 month after the final treatment), the median inflammatory lesion count (n=10 subjects with complete data) decreased from 22.0 (inter-quartile range) to 10.5 (P=0.0196). For noninflammatory lesions, the median counts decreased from 25.0 to 10.0 (P=0.0956). The corresponding reduction percentages ([baseline count-post treatment count/baseline count] X100) were 78.8 percent for inflammatory lesion counts and 57.8 percent for noninflammatory lesion counts. At 153 days (n=6 with complete data), reductions were significant for both inflammatory (P=0.0137) and noninflammatory (P=0.0383) counts.
In a study involving 20 patients with mild-to-severe facial acne who were treated with a combination of pulsed light and vacuum, Wankiphakdeedecha et al12 reported that the greatest improvements in acne clearance were achieved in patients with severe acne.
THERACLEAR® X ACNE SYSTEM OVERVIEW
The TheraClear®X Acne System (Strata Skin Sciences, Horsham, Pennsylvania) delivers a combination of broadband pulsed light (500–1200nm) concurrent with the application of vacuum.8,13 The TheraClearX system is technologically based on principals of physics and biology, and functions by mechanically clearing congested follicles of the affected pilosebaceous apparatus using a suction-activated tip while simultaneously administrating broadband light with a cut-off filter from 500 to 1200nm to activate endogenous porphyrins in pathogenic bacteria. The device is capable of generating vacuum with pressure up to three pounds per square inch (psi) in a confined treatment area, which effectively lifts the dermal structures toward the epidermis and expels follicular contents onto the skin’s surface.8,9,14
MECHANISM OF ACTION
The TheraClearX device works by placing the treatment chamber over the area to be treated. When complete contact with the treatment surface is detected, a vacuum is applied, drawing affected skin into the treatment chamber. The effect of vacuum elevates the sebaceous gland toward the surface, momentarily stretching the skin 25 to 35 percent, extracting the obstructed sebaceous material. An array of flash lamps subsequently irradiate the treatment area. Along with targeted heating of the dermis, the endogenous effect of light activates porphyrins to destroy Cutibacterium acnes (C. acnes) and reduce sebum production. When the process is completed, the vacuum is released and the skin is normalized.
Therapeutic effect of vacuum. The immediate and rapid pressure change on the follicular ostia of the pilosebaceous unit dislodges keratin plugs and allows evacuation of sebum onto the surface of the skin. When sebum is extracted from the clogged pilosebaceous duct, various commensal and pathogenic bacteria residing in the pilosebaceous unit are simultaneously extruded or thermally injured.15 In studies conducted with similar devices, researchers demonstrated that both antibiotic-resistant and antibiotic-susceptible bacteria can be mechanically extruded.7 These reports indicated that much of the bacteria was antibiotic-resistant and presumably unresponsive to topical or oral antibiotics. Mechanical extrusion of bacteria significantly reduced bacterial load on the sebaceous gland, effectively diminished the localized inflammation, and clinically resolved the acne lesions.7,12
Endogenous effect of light. The TheraClearX system uses a series of xenon flash lamps that provide a broadband output ranging from 500 to 1200nm. An optical coating removes the shorter wavelengths that can potentially damage the heavily melanated epidermis of patients with darker skin types, making the spectrum safe for the treatment of all Fitzpatrick skin types (I–VI).
The sebaceous material that clogs the pilosebaceous duct causing inflammatory acne is composed of a variety of substances, including sebum and tissue (e.g., keratin, melanin) that once formed the epidermis. Consequently, this sebaceous material’s absorption spectrum is more complex than the absorption spectrum of porphyrins associated with C. acnes bacteria. In the study by Chang et al,7 investigators collected the extracted sebaceous material to determine its absorption spectrum, reporting that sebum closely resembles that of melanin. This observation is not surprising when one considers that melanin is one of the major constituents of this extruded sebaceous material.
Comparing the spectral output of the TheraClearX system to the absorption spectrum of the material extracted from the sebaceous gland, light output between 800 and 1000nm plays an important role in heating this material. Consistent with clinical literature, the broadband light source of the TheraClearX system activates endogenous porphyrins and also has an effect on perilesional erythema/inflammation due to absorption in the 500 to 600 nm range.10–15
KEY FEATURES
Continuously cooled handpiece. Continuous cooling keeps the walls of the treatment chamber cool for added safety for both patient and provider. In other products, the metallic walls must be manually cooled every 5 to 10 pulses of light with an exogenous cryogen spray. However, TheraClearX device’s continuously cooled treatment inserts allow the operator to perform the treatments quickly and with less risk of error, which could potentially occur with frequent pauses to manually cool skin.
Water temperature sensors. In the TheraClearX device, sensors monitor water temperatures keeping temperature in a safe range. In older vacuum and light technologies, the only indication that the walls exceeded safe temperatures was the clinical appearance of the treated skin and the pain response of the patient.
Water cooled lamps. The TheraClearX device uses water-cooled lamps to increase lamp life and reduce the cost of consumables.
Customizable vacuum settings. TheraClearX’s customizable vacuum settings allow for microadjustments to the vacuum, making the treatment more comfortable for the patient and allowing better access on previously challenging areas. Three new soft vacuum modes greatly reduce potential for purpura on sensitive areas such as the forehead, temples, and nose.
Single light filter optimizes spectral output for all Fitzpatrick skin types. A highly optimized spectral output allows for a single light filter to effectively treat all skin types, including Fitzpatrick Skin Types IV to V patients.
Soft silicon treatment inserts. All treatment inserts have soft silicon flanges that enable easier contact with the treatment area and enhance patient comfort, especially when treating aggravated areas.
CLINICAL OUTCOMES
The TheraClearX system is US Food and Drug Administration (FDA)-cleared for the treatment of mild-to-moderate inflammatory, comedonal, and pustular acne on all skin types.
Treatment protocols. Treatment Protocol: Prior to treatment, gentle cleansing with a warm washcloth helps soften skin and helps facilitate extraction of comedones. Energy settings are selected based on skin types. Vacuum settings are selected based on treatment areas, with vacuum settings being reduced when treating delicate areas, such as the forehead.
For all our patients, we use a double pulse with two passes over the entire face. Patients are typically treated at weekly intervals for 4 to 5 treatments, based on the severity of acne.
Evaluation and outcomes. Patients in our clinic who were treated with TheraClearX were evaluated using standardized photographs. Each patient was photographed before first treatment and then before each one of five subsequent treatments. Patients were evaluated for a reduction in lesions, a reduction in erythema (redness) caused by acne, changes in skin texture and improvements in skin texture. Patients were also evaluated for treatment related side effects.
All patients demonstrated at least a 50-percent improvement in lesion counts post-first treatment. Subjective evaluations included a visible reduction in redness around acne lesions as well as visible reduction in crusting. The majority of patients reported a reduction in redness 24 to 72 hours post-first treatment.
Patients uniformly described the treatment as being very comfortable. Consequently, adherence rates were high for all study patients. Patients also reported less oily skin. This was also visible upon skin evaluation. Patients with hyperpigmentation caused by acne noted visibly more even skin tone after first treatment. Patients with large pores reported a reduction in pore size and a consequent improvement in skin texture.
No significant side effects were reported. The most commonly reported treatment-related side effect was minor purpura that resolved 24 to 72 hours post-treatment. This was not observed when using the soft vacuum modes on the device. Immediate post-treatment skin reactions were limited to localized mild and transient erythema, which resolved within 30 minutes of treatment. Patients reported satisfaction with outcomes.
CONCLUSION
Our experience to date demonstrates that TheraClearX treatments are well tolerated by patients and effective for the treatment of a wide range of mild-to-severe acne. There was little to no discomfort during treatments and no downtime. No anesthetics or numbing gels were used prior to treatment. Most noticeably, patients noted an immediate reduction in redness post first treatment as is indicated by the photographs.
While these initial findings warrant larger scale randomized studies, we do believe that the TheraClearX System is effective for the treatment of a wide range and severity of acne.
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