Laser Treatment of Moderate to Severe Acne Vulgaris

Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Device: Laser Intervention

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • MGH Clinical Unit for Research Trials & Outcomes in Skin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects in this arm will undergo laser treatment on their active acne vulgaris lesions. Subjects will serve as their own control.	Device: Laser Intervention; Subjects with undergo laser exposure of their active acne vulgaris.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Physician's Global Assessment (PGA) of Acne Severity	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	Change in PGA score between baseline visit and post procedural visit

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Dieter Manstein, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Acne; Acne Vulgaris; Laser; Cystic Acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 2020P000838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No