Laser Treatment of Moderate to Severe Acne Vulgaris

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04466527
Collaborator
(none)
22
1
1
18.4
1.2

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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022