Study Evaluating the Efficacy and Safety of TheraClearX on Mitigating Mild to Moderate Acne

NCT06043102 | Completed FDA Device

• 1 other identifier: SSKN-TCX-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline to Day 49 or End of Study (EOS) visit

Secondary Outcomes (4)

• Improvement in Acne QoL questionnaire scores

  Baseline to Day 49 or End of Study (EOS) visit

• Improvement in Acne Self Assessment questionnaire scores

  Baseline to Day 49 or End of Study (EOS) visit

• Favorable Analysis of the Acne Subject Satisfaction questionnaire

  Day 49 or EOS visit

• Favorable Analysis of the Subject Consumer Perception questionnaire

  Day 49 or EOS visit

Other Outcomes (4)

• Improvement in the VISIA photography imaging of the left, right and front views of the face.

  Baseline to Day 49 or EOS visit

• The frequency of both local and systemic AE's

  Baseline, Day 7, Day 14, Day 21, Day 28, Day 35 and Day 49 or End of Study visit.

• Investigator Tolerability Assessment (erythema, edema, dryness, scaling, hypopigmentation and hyperpigmentation)

  Baseline, Day 7, Day 14, Day 21, Day 28, Day 35 and Day 49 or End of Study visit.

Study Arms (1)

TheraClearX treatment

OTHER

TheraClearX treatment of the facial area weekly for 6 sessions.

Device: TheraClearX

Interventions

TheraClearX DEVICE

TheraClear®X combines vacuum pressure with a broadband light source (500 nm to 1,200 nm) to treat facial acne.

TheraClearX treatment

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ablon Skin Institute Research Center: lead
• Strata Skin Sciences: collaborator

Study Sites (1)

Ablon Skin Institute & Research Center

Manhattan Beach, California, 90266, United States

Location

Related Publications (1)

• 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.

  PMID: 38912192 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open label study evaluating the efficacy and safety
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label study evaluating the efficacy and safety

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: May 16, 2023
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: April 6, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)