Acne Vulgaris Clinical Trial
Official title:
Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial
Verified date | January 2024 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | MGH Clinical Unit for Research Trials & Outcomes in Skin | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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 |
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