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Laser Treatment of Moderate to Severe Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser Intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, Acne Vulgaris, Laser, Cystic Acne

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • MGH Clinical Unit for Research Trials & Outcomes in Skin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 2, 2020
Last Updated
April 21, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04466527
Brief Title
Laser Treatment of Moderate to Severe Acne Vulgaris
Official Title
Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, Acne Vulgaris, Laser, Cystic Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects in this arm will undergo laser treatment on their active acne vulgaris lesions. Subjects will serve as their own control.
Intervention Type
Device
Intervention Name(s)
Laser Intervention
Intervention Description
Subjects with undergo laser exposure of their active acne vulgaris.
Primary Outcome Measure Information:
Title
Changes in Physician's Global Assessment (PGA) of Acne Severity
Description
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
Time Frame
Change in PGA score between baseline visit and post procedural visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Manstein, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neera Nathan, MD, MSHS
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH Clinical Unit for Research Trials & Outcomes in Skin
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Laser Treatment of Moderate to Severe Acne Vulgaris

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