Active — Not RecruitingNot Applicable

Laser Treatment of Moderate to Severe Acne Vulgaris

United States22 participantsStarted 2021-05-20

Plain-language summary

In this study, we are enrolling subjects with moderate to severe acne vulgaris and investigating the use of a commercially available laser in treating acne.

Who can participate

Age range18 Years – 40 Years

SexALL

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Inclusion criteria

✓. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
✓. In good general health, based on answers provided during the screening visit;
✓. Subject must be able to read and understand English;
✓. Any gender and any Fitzpatrick skin type;
✓. Ages 18 through 40;
✓. Subjects must have moderate to severe nodular active facial acne vulgaris (PGA 3 or 4)
✓. Willing to sun protect treated area for the duration of enrollment in the study and 1 year after treatment;
✓. Subjects must be ineligible for or have declined standard of care treatments (e.g. oral isotretinoin therapy).

Exclusion criteria

✕. Participation in another investigational drug or device clinical trial in the past 30 days;
✕. Currently undergoing or wish to begin or continue topical treatments;
✕. Are pregnant or lactating;
✕. History of allergic reaction to topical anesthesia;
✕. Subjects may not have undergone oral isotretinoin therapy within the past 12 months;
✕. Currently take oral antibiotic or oral therapy for acne;
✕. History of keloidal or hypertrophic scarring;
✕. Laser treatment in past six months;

What they're measuring

Changes in Physician's Global Assessment (PGA) of Acne Severity

Timeframe: Change in PGA score between baseline visit and post procedural visit

Trial details

NCT IDNCT04466527

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

View on ClinicalTrials.gov More Acne Vulgaris trials