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Laser Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466527
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Dieter Manstein, MD, Massachusetts General Hospital

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
Acne Vulgaris Device: Laser Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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.




Primary Outcome Measures :
  1. Changes in Physician's Global Assessment (PGA) of Acne Severity [ Time Frame: Change in PGA score between each of study visit, for up to 6 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Exclusion Criteria:

  • Participation in another investigational drug or device clinical trial in the past 30 days;
  • Are pregnant or lactating;
  • History of allergic reaction to topical anesthesia;
  • Subjects may not have undergone oral isotretinoin therapy within three months;
  • Currently take oral antibiotic or oral therapy for acne;
  • History of keloidal or hypertrophic scarring;
  • Laser treatment in past six months;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466527


Contacts
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Contact: Clinical Research Coordinator II (216) 385-1990 dkarasik@mgh.harvard.edu
Contact: Neera Nathan, MD, MSHS (240) 285-1119 nnathan2@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Dieter Manstein, MD, PhD Massachusetts General Hospital
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Responsible Party: Dieter Manstein, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04466527    
Other Study ID Numbers: 2020P000838
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Massachusetts General Hospital:
Acne
Acne Vulgaris
Laser
Cystic Acne
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases