Laser Treatment of Moderate to Severe Acne Vulgaris

NCT ID: NCT04466527

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2025-11-30

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Laser Intervention

Intervention Type: DEVICE

Subjects with undergo laser exposure of their active acne vulgaris.

Interventions

Laser Intervention

Subjects with undergo laser exposure of their active acne vulgaris.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dieter Manstein, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dieter Manstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

MGH Clinical Unit for Research Trials & Outcomes in Skin

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2020P000838

Identifier Type: -

Identifier Source: org_study_id