Study Evaluating the Efficacy and Safety of TheraClearX on Mitigating Mild to Moderate Acne (NCT06043102) | Clinical Trial Compass
CompletedNot Applicable
Study Evaluating the Efficacy and Safety of TheraClearX on Mitigating Mild to Moderate Acne
United States30 participantsStarted 2023-05-16
Plain-language 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.
Who can participate
Age range12 Years – 40 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in inflammatory lesion counts
Timeframe: Baseline to Day 49 or End of Study (EOS) visit
2
Change in non-inflammatory lesion counts
Timeframe: Baseline to Day 49 or End of Study (EOS) visit
3
Percentage/Proportion of subjects who achieve at least a one-grade reduction in the IGA Score
Timeframe: Baseline to Day 49 or End of Study (EOS) visit
✕. 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.