Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT06043102
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2023-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating the Efficacy and Safety of TheraClearX on Mitigating Mild to Moderate Acne
Sponsor:
Ablon Skin Institute Research Center
Organization:
Study Overview
Official Title:
A 7 Week, Open Label, Study Evaluating the Efficacy and Safety of TheraClearX on Mitigating Mild to Moderate Acne in Healthy Teenagers and Young Adults
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: