Laser Treatment of Moderate to Severe Acne Vulgaris

NCT04466527 | Terminated Results FDA Device

• 1 other identifier: 2020P000838
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Vulgaris

Keywords

Acne; Acne Vulgaris; Laser; Cystic Acne

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Physician's Global Assessment (PGA) Score

  3 months

Study Arms (2)

Full-face treatment

EXPERIMENTAL

3 laser sessions (whole face), up to 22 subjects

Device: Laser Intervention

Localized treatment

EXPERIMENTAL

1 laser session on 1-3 selected lesions, up to 22 subjects

Device: Laser Intervention

Interventions

Laser Intervention DEVICE

Subjects receive laser treatment.

Full-face treatment; Localized treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Clinical Unit for Research Trials & Outcomes in Skin

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Limitations and Caveats

The study was designed with two arms; however, only Arm 1 (full-face ablative fractional CO₂ laser, 3 treatments) was conducted. Arm 2 (focal/localized treatment of 1-3 lesions, single treatment) was not initiated as resources and recruitment were prioritized for Arm 1. Results presented reflect Arm 1 only, with 4 participants completing the full protocol.

Results Point of Contact

• Title: Dieter Manstein
• Organization: Massachusetts General Hospital

mansteinlab@mgh.harvard.edu

617-726-4454

Study Officials

• Dieter Manstein, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 10, 2020
• Study Start: November 9, 2020
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: June 1, 2026
• Results First Posted: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)