Laser Treatment of Moderate to Severe Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04466527
• Other study ID #: 2020P000838
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Device:
• Laser Intervention
Subjects with undergo laser exposure of their active acne vulgaris.

Locations

Country	Name	City	State
United States	MGH Clinical Unit for Research Trials & Outcomes in Skin	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in PGA score between baseline visit and post procedural visit