Laser Treatment of Moderate to Severe Acne Vulgaris

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

The goal of this clinical trial is to learn if fractional ablative laser can treat active acne vulgaris in adults 18 to 40 years old with moderate to severe acne vulgaris.

The main questions it aims to answer are:

Does ablative fractional carbon dioxide treatment effectively treat moderate to severe active nodular acne vulgaris?

Does ablative fractional carbon dioxide treatment effectively treat moderate to severe active nodular acne vulgaris over a short time frame?

Is non-selective laser useful in treating inflammatory skin disease?

How does the microbiome change after laser treatment?

Participants will...

• Receive up to 3 laser treatments
• Attend a baseline visit and follow-up visits post-treatment where participants will receive a clinical assessment, facial swab, and facial-imaging

Study Overview

• Status: Terminated
• Conditions: Acne Vulgaris
• Intervention / Treatment: Device: Laser Intervention

Detailed Description

This study is designed to evaluate the efficacy of ablative fractional laser treatment for the clinical improvement or treatment of active acne vulgaris. We will be performing a self-controlled study, where each eligible subject will serve as their own control. Each subject will receive an ablative fractional 10,600 nm carbon dioxide laser treatment (Lumenis® Ultrapulse® C02 laser with DeepFX™ Yokneam, Israel).

There is another arm in the study. 22 subjects with acne will be selected to do the same laser treatment on a localized part of the face (1-3 inflammatory lesions and up to 5 mm adjacent area).

We plan to have 22 subjects complete the study on the first arm and 22 on the second arm. Both arms will be treated with the same device and the same energy and density will be used. The first arm will be submitted to 3 laser treatments, with a one-month interval between each treatment appointment and their full face will be treated. The second arm will have only one treatment and only 1-3 lesions will be submitted to the laser treatment.

• Study Type: Interventional
• Enrollment (Actual): 4
• 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: No

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: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full-face treatment; 3 laser sessions (whole face), up to 22 subjects	Device: Laser Intervention; Subjects receive laser treatment.
Experimental: Localized treatment; 1 laser session on 1-3 selected lesions, up to 22 subjects	Device: Laser Intervention; Subjects receive laser treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lesion Count	Lesion count is a tally of all different types of blemishes (comedones, papules, pustules, nodules, cysts) on the face. In this study, change in lesion count represents the change in subjects' lesion count post-treatment. A negative change in lesion count indicates that acne improved whereas a positive change in lesion count indicates that acne worsened.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physician's Global Assessment (PGA) Score	The Physician's Global Assessment (PGA) score is a clinical scale used by dermatologists to rate the overall severity of acne at a given time. The Acne PGA scales range from 0 to 4 (with 0 being least severe and 4 being most severe). In this study, change in PGA score represents the change in subjects' PGA score following treatment. A negative change in PGA score indicates that acne improved whereas a positive change in PGA score indicates that the acne worsened.	3 months

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): November 9, 2020
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): July 27, 2022

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): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

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; Skin and Connective Tissue 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