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Laser Treatment of Moderate to Severe Acne Vulgaris

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04466527
Collaborator
(none)
22
Enrollment
1
Location
1
Arm
18.4
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Laser Intervention
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial
Actual Study Start Date :
May 20, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 MGH Clinical Unit for Research Trials & Outcomes in Skin Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Dieter Manstein, MD, PhD, Massachusetts General Hospital
  • Principal Investigator: Neera Nathan, MD, MSHS, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dieter Manstein, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT04466527
Other Study ID Numbers:
  • 2020P000838
First Posted:
Jul 10, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Dieter Manstein, MD, Principal Investigator, Massachusetts General Hospital
Acne
Acne Vulgaris
Laser
Cystic Acne
Additional relevant MeSH terms:
Acne Vulgaris

Study Results

No Results Posted as of Mar 2, 2022