The goal of this clinical trial is to further substantiate the effectiveness and safety of TheraClearX as a stand-alone treatment of mild to moderate acne in healthy teenagers and adults ages 12-40 over the course of 7 weeks. Participants will be asked to have TheraClearX treatments weekly for 6 sessions, attend a follow up appointment 2 weeks after the 6th session, have photos taken of their face and answer questionnaires related to their acne.
Acne is a common disease of the pilosebaceous unit affecting both teenagers and young adults that causes both physical and emotional damage. The risk of delaying treatment is that of scarring which can be devastating for patients of all ages. The pathogenesis is complex and appears to involve 4 primary features: increased stimulation of sebum gland activity, increased bacterial proliferation (especially Propionibacterium acnes), abnormal follicular hyperkeratinization and resultant obstruction of the sebaceous follicles, and the release of inflammatory mediators. These changes in acne patients result in the formation of clinical inflammatory lesions including superficial pustules such as comedones (popularly known as "blackheads" or "whiteheads") and more deeply located pustules, papules, nodules and cysts. Due to the complexity of pathogenic mechanisms causing acne, treatment typically includes combination therapy including topical applications, oral medications, and numerous alternative therapies including lasers, light, steroid injections, chemical peels, and extractions. Many of these treatments while effective if used for a sustained period of time, have side effects, complications, and resistance. So it is important to consider alternative therapeutic options. The application of lasers and light-based systems in the field of dermatology has dramatically advanced based on Anderson and Parish's theory of selective photothermolysis in which very short pulses of laser energy with high peak powers at a given wavelength are selectively absorbed by target chromophores such as melanin and hemoglobin, but delivering minimum damage to the normal tissue surrounding the target. The application of these lasers in the extended theory of photothermolysis has currently expanded to include the treatment of acne. Recently, a novel device called TheraClear®X, that combines vacuum pressure with a broadband light source (500 nm to 1,200 nm) was developed for the treatment of acne. Unlike currently available devices, TheraClear®X uses gentle pneumatic energy to draw the target tissue into the treatment tip, with negative pressure lifting the sebaceous gland and thus bringing it closer to the surface of the skin. The vacuum then elevates and everts the sebaceous gland, allowing it to open up and empty its contents, ejecting the acne causing bacteria, sebum, dead skin cells, and other impurities onto the surface of the skin. Such photopneumatic devices are the only pulsed broadband light therapy approved by the United States Food and Drug Administration for the treatment of comedonal and pustular acne, as well as inflammatory acne. Inflammation caused by acne also has a major vascular component, which appears as redness. Pulsed light is an ideal energy source to remove this redness. Being able to offer comfortable, low risk treatment options for patients suffering with acne is critical as more patients are looking for these options. This clinical trial is therefore a critical addition to the armamentarium of acne treatments. The proposed clinical study will substantiate the efficacy and safety of TheraClear®X as a stand-alone treatment for the mitigation of mild to moderate acne in healthy teenagers and young adults.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
TheraClear®X combines vacuum pressure with a broadband light source (500 nm to 1,200 nm) to treat facial acne.
Ablon Skin Institute & Research Center
Manhattan Beach, California, United States
Change in inflammatory lesion counts
Papule - A small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin. Pustule - A small circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate. Nodule - An inflammatory lesion greater than or equal to 5 mm in diameter. Cyst - An inflammatory lesion that contains yellow-white exudate that is greater than or equal to 5mm in diameter.
Time frame: Baseline to Day 49 or End of Study (EOS) visit
Change in non-inflammatory lesion counts
Open Comedone - (Black head) A lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin, with compacted melanin cells giving the plug a black appearance. Closed Comedone - (White head) A lesion in which the follicle opening is closed, but the sebaceous gland is enlarged by the pressure of the sebum buildup, which in turn cause the skin around the follicle to thin and become elevated with a white appearance.
Time frame: Baseline to Day 49 or End of Study (EOS) visit
Percentage/Proportion of subjects who achieve at least a one-grade reduction in the IGA Score
The Investigator will use the Investigator Global Assessment (IGA) Scale to assess the severity of a subjects' acne. The IGA Scale is a static evaluation of global severity representing clinically meaningful graduations of the disease. The IGA should be performed prior to the lesion count. Subjects are eligible for enrollment if they have facial acne with a global severity grade of a 2 (mild) or a 3 (moderate) on the IGA scale at Baseline. If at Visits Day 7, Day 14, Day 21, Day 28 or Day 35 the subject has an IGA Scale rating of Zero (0)/Clear then the subject will proceed to the EOS Visit two (2) weeks following that Visit and no further TheraClear®X Procedures will be performed.
Time frame: Baseline to Day 49 or End of Study (EOS) visit
Improvement in Acne QoL questionnaire scores
The Acne-specific Quality of Life questionnaire (Acne QoL) is a health-related quality of life instrument developed by MERCK \& CO., INC. for use in clinical trials to assess the impact of therapy on quality of life among subjects with facial acne. The Acne QoL questionnaire consists of 19 questions. The Acne QoL is self-administrated (i.e. the subject is able to complete the questionnaire without assistance or interpretation from study staff) and should take approximately 10 minutes or less to complete. The scale is called Acne-Specific Quality of Life Questionnaire and the scale goes from 0 (not at all) to 6 (extremely). A decrease in response values (lower scores means a better outcome) at Day 49 or EOS indicates an improvement compared to baseline response values.
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Time frame: Baseline to Day 49 or End of Study (EOS) visit
Improvement in Acne Self Assessment questionnaire scores
The Acne Self-Assessment Questionnaire will ask subjects a series of questions related to their facial acne and overall facial skin appearance. The scale is called the Acne Self-Assessment quesitonnaire and the scale goes from 0 (Very satisfied) to 5 (Very dissatisfied). A decrease in response values (lower scores means a better outcome) at Day 49 or EOS indicates an improvement compared to baseline response values.
Time frame: Baseline to Day 49 or End of Study (EOS) visit
Favorable Analysis of the Acne Subject Satisfaction questionnaire
The Acne Subject Satisfaction Questionnaire will ask subjects a series of questions related to their opinion of treatment satisfaction. The scale is called the Acne Subject Satisfaction questionnaire and the scale goes from 1 (Very Satisfied) to 5 (Very Dissatisfied). Favorable analysis at Day 49 or EOS would be indicated by low response values.
Time frame: Day 49 or EOS visit
Favorable Analysis of the Subject Consumer Perception questionnaire
The Subject Consumer Perception Questionnaire will ask subjects a series of questions related to their opinion of what is important to them when choosing an acne treatment. The scale is called the Subject Consumer Perception questionnaire and the scale goes from 1 (Very Likely) to 5 (Very Unlikely). Favorable analysis at Day 49 or EOS would be indicated by low response values.
Time frame: Day 49 or EOS visit