AcneNCT06043102
Study Evaluating the Efficacy and Safety of TheraClearX on Mitigating Mild to Moderate Acne
A study testing TheraClearX in people with Acne, run by Ablon Skin Institute Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- TheraClearX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 18 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy male or females of all Fitzpatrick Skin Types between 12 and 40 years of age.
- Subjects must be willing to provide verbal understanding and sign an Informed Consent Form, HIPAA Form and Photography Release Form approved by the Institutional Review Board. Subjects less than age of consent must sign an assent for the study and a parent must sign the informed consent (if subject reaches the age of consent during the study they should be re-consented at the next study visit).
- Subjects must be in general good health, as determined by the Investigator.
- Subjects must be willing and able to attend all study visits and comply with the Pre and Post Treatment Instructions.
- Subjects must be willing to have VISIA facial photography imaging of their entire face for overall evaluation of their skin at all Visits.
- Subjects must be willing and able to complete and understand the various rating questionnaires.
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- Subjects must have an IGA score of 2 (mild) or 3 (moderate) at the Baseline Visit.
- Subjects must have a facial acne inflammatory lesion (papules, pustules, and nodules) count with no less than 10 but no more than 50 at the Baseline Visit.
- Subjects must have a facial acne non-inflammatory lesion (open and closed comedones) count with no less than 10 but no more than 100 at the Baseline Visit.
- Subjects with 1 or fewer facial nodules at the Baseline Visit.
- Females of child bearing potential (FOCBP) and females who are premenses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, intrauterine device, condom with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type pill for at least 3 months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to the start of the study. Women who use birth control for acne control only should be excluded.
- Premenses females and FOCBP must have a negative urine pregnancy test at the Baseline Visit.
- Subjects must be willing to comply with study instructions and return to the clinic for required visits.
- Subjects must be willing to use the cleanser, moisturizer and sunscreen provided by the Sponsor.
- If the subject wears makeup, they must agree to use non-comedogenic makeup.
- Male subjects facial area must be clean-shaven for all study visits as to not interfere with study treatments and assessments.
Who cannot join
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
- Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, Gram- negative folliculitis, dermatitis, eczema.
- Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
- Subjects with more than 50 facial acne inflammatory lesions (papules, pustules, and nodules)
- Subjects with more than 100 facial acne non-inflammatory lesions (open and closed comedones)
- Subjects with more than one (1) facial nodule.
Show all 25Show fewer
- Subjects with a facial beard or mustache that could interfere with the study assessments.
- Subjects who have a history of experiencing significant burning or stinging when applying any facial treatment (eg, makeup, soap, masks, washes, sunscreens, etc) to their face.
- Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
- If female, subject has a history of hirsutism, polycystic ovarian disease or clinically significant menstrual irregularities.
- Subjects who have a history of light-induced seizures or diseases that may be stimulated by visible light.
- Subjects currently using photosensitive medications or herbal supplements (ie. Tetracycline and St. John's Wart).
- Subjects who have a history of blood disorders that alter the ability of blood to coagulate and/or are currently taking anti-coagulants or blood thinning medications.
- Subjects who have a history of keloid and hypertrophic scar formation.
- Subjects who have a history of Herpes Simplex in the treatment area, connective tissue damage, immunosuppressive diseases, Systemic Lupus Erythematosus and Porphyria.
- Subjects who currently have active infections, broken skin, extremely dry skin or open lesions in the treatment area.
- Treatment of any type of cancer within the last 6 months in the facial area, with the exception of complete surgical excision of skin cancer outside the treatment area.
- Subjects who have not undergone the specified washout period(s) for the following topical preparations/physical treatments used on the face or subjects who require the concurrent use of any of the following in the treatment area:
- Topical astringents and abrasives on the face 1 week Non-allowed moisturizers or sunscreens on the face 1 week Acne surgery 1 week Antibiotics on the face 2 weeks Other topical anti-acne drugs on the face 2 weeks Soaps containing antimicrobials on the face 2 weeks Light (e.g. LED, PDT) therapy on the face 2 weeks Anti-inflammatory agents and corticosteroids on the face 4 weeks Retinoids, including retinol on the face 4 weeks Chemical peel/Microdermabrasion on the face 4 weeks Laser therapy on the face 4 weeks
- Subjects who have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:
- Corticosteroids (including intramuscular injections) (inhaled corticosteroids are allowed) 4 weeks Antibiotics 4 weeks Other systemic acne treatments 4 weeks Systemic retinoids 6 months
- Subjects who have had Botulinum Toxin or Filler in the facial area in the last 2 weeks or are planning on having Botulinum Toxin or Filler during the duration of the study.
- Subject intends to use a tanning booth or sunbathe during the study.
- Subjects who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ablon Skin Institute & Research Center
Manhattan Beach, California, 90266
About this study
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
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.
Read the 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.
- Conditions
- Acne
- Being tested
- TheraClearX
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraClearXDevice
TheraClear®X combines vacuum pressure with a broadband light source (500 nm to 1,200 nm) to treat facial acne.
| Study group | Role | What they receive |
|---|---|---|
| TheraClearX treatment | Other | TheraClearX treatment of the facial area weekly for 6 sessions. Receives: Device: TheraClearX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 49 or End of Study (EOS) visit
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 49 or EOS visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start16 May 2023
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label study evaluating the efficacy and safety
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablon Skin Institute Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Strata Skin Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043102
- Sponsor's protocol ID
- SSKN-TCX-01
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ablon G. A Seven-week, Open-label Trial Evaluating the Safety and Efficacy of a Photopneumatic Device for Mitigating Mild-to-Moderate Acne in Healthy Adolescents and Young Adults. J Clin Aesthet Dermatol. 2024 Jun;17(6):13-20.
PubMed 38912192
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06043102
- Acronym / sponsor ID
- SSKN-TCX-01
- Conditions
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ablon Skin Institute Research CenterUniversity, hospital or other
- Collaborators
- Strata Skin Sciences
- Study start
- 16 May 2023 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label study evaluating the efficacy and safety
| Arm | Type | Receives |
|---|---|---|
| TheraClearX treatment | Other | Device: TheraClearXTheraClearX treatment of the facial area weekly for 6 sessions. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Healthy male or females of all Fitzpatrick Skin Types between 12 and 40 years of age.
- Subjects must be willing to provide verbal understanding and sign an Informed Consent Form, HIPAA Form and Photography Release Form approved by the Institutional Review Board. Subjects less than age of consent must sign an assent for the study and a parent must sign the informed consent (if subject reaches the age of consent during the study they should be re-consented at the next study visit).
- Subjects must be in general good health, as determined by the Investigator.
- Subjects must be willing and able to attend all study visits and comply with the Pre and Post Treatment Instructions.
- Subjects must be willing to have VISIA facial photography imaging of their entire face for overall evaluation of their skin at all Visits.
Key exclusion criteria (25 listed)
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
- Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, Gram- negative folliculitis, dermatitis, eczema.
- Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
- Subjects with more than 50 facial acne inflammatory lesions (papules, pustules, and nodules)
- Subjects with more than 100 facial acne non-inflammatory lesions (open and closed comedones)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraClearXTheraClear®X combines vacuum pressure with a broadband light source (500 nm to 1,200 nm) to treat facial acne. | Device | TheraClearX treatment |
Primary outcome
Change in inflammatory lesion counts
Time frame: Baseline to Day 49 or End of Study (EOS) visit
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.
Change in non-inflammatory lesion counts
Time frame: Baseline to Day 49 or End of Study (EOS) visit
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.
Percentage/Proportion of subjects who achieve at least a one-grade reduction in the IGA Score
Time frame: Baseline to Day 49 or End of Study (EOS) visit
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.
4 secondary outcomes
Improvement in Acne QoL questionnaire scores
Time frame: Baseline to Day 49 or End of Study (EOS) visit
Improvement in Acne Self Assessment questionnaire scores
Time frame: Baseline to Day 49 or End of Study (EOS) visit
Favorable Analysis of the Acne Subject Satisfaction questionnaire
Time frame: Day 49 or EOS visit
Favorable Analysis of the Subject Consumer Perception questionnaire
Time frame: Day 49 or EOS visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 38912192Ablon G. A Seven-week, Open-label Trial Evaluating the Safety and Efficacy of a Photopneumatic Device for Mitigating Mild-to-Moderate Acne in Healthy Adolescents and Young Adults. J Clin Aesthet Dermatol. 2024 Jun;17(6):13-20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraClearX in people with Acne, run by Ablon Skin Institute Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammatory lesion counts (time frame: Baseline to Day 49 or End of Study (EOS) visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06043102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.