Laser Treatment of Moderate to Severe Acne Vulgaris

Mass General Brigham

Status: Active, not recruiting

Conditions: Acne Vulgaris

Treatments: Device: Laser Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04466527

2020P000838

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Participation in another investigational drug or device clinical trial in the past 30 days;
2. Currently undergoing or wish to begin or continue topical treatments;
3. Are pregnant or lactating;
4. History of allergic reaction to topical anesthesia;
5. Subjects may not have undergone oral isotretinoin therapy within the past 12 months;
6. Currently take oral antibiotic or oral therapy for acne;
7. History of keloidal or hypertrophic scarring;
8. Laser treatment in past six months;
9. History of poor wound healing;
10. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

Treatment

Experimental group

Description:

Subjects in this arm will undergo laser treatment on their active acne vulgaris lesions. Subjects will serve as their own control.

Treatment:

Device: Laser Intervention