Laser Treatment of Moderate to Severe Acne Vulgaris

Not Applicable

Active, not recruiting

• Conditions: Acne Vulgaris
• Interventions: Device: Laser Intervention

• Registration Number: NCT04466527
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-10
• Study Start: 2021-05-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Laser Intervention	Subjects in this arm will undergo laser treatment on their active acne vulgaris lesions. Subjects will serve as their own control.

Primary Outcome Measures

Name	Time	Method
Changes in Physician's Global Assessment (PGA) of Acne Severity	Change in PGA score between baseline visit and post procedural visit	The physician will score the acne vulgaris based on the Physician's Global Assessment (PGA) scale. A score of 0 indicates that residual hyperpigmentation and erythema may be present; a score of 1 indicates that there are a few scattered comedones and a few small papules; a score of 3 indicates that more than half of the face is involved, that there are many comedones, papules, and pustules, and that one nodule may be present; a score of 4 indicates that the entire face is involved, covered with comedones, numerous papules and pustules, and a few nodules and cysts. The change in PGA score will be recorded at each of the 4 study visits, for up to

Trial Locations

Locations (1)

MGH Clinical Unit for Research Trials & Outcomes in Skin; 🇺🇸 Boston, Massachusetts, United States