Status:
ACTIVE_NOT_RECRUITING
Laser Treatment of Moderate to Severe Acne Vulgaris
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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;
- History of poor wound healing;
- Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04466527
Start Date
May 20 2021
End Date
November 1 2025
Last Update
January 16 2025
Active Locations (1)
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1
MGH Clinical Unit for Research Trials & Outcomes in Skin
Boston, Massachusetts, United States, 02114