Acne Vulgaris
Conditions
Keywords
Acne, Acne Vulgaris, Laser, Cystic Acne
Brief summary
The goal of this clinical trial is to learn if fractional ablative laser can treat active acne vulgaris in adults 18 to 40 years old with moderate to severe acne vulgaris. The main questions it aims to answer are: Does ablative fractional carbon dioxide treatment effectively treat moderate to severe active nodular acne vulgaris? Does ablative fractional carbon dioxide treatment effectively treat moderate to severe active nodular acne vulgaris over a short time frame? Is non-selective laser useful in treating inflammatory skin disease? How does the microbiome change after laser treatment? Participants will... * Receive up to 3 laser treatments * Attend a baseline visit and follow-up visits post-treatment where participants will receive a clinical assessment, facial swab, and facial-imaging
Detailed description
This study is designed to evaluate the efficacy of ablative fractional laser treatment for the clinical improvement or treatment of active acne vulgaris. We will be performing a self-controlled study, where each eligible subject will serve as their own control. Each subject will receive an ablative fractional 10,600 nm carbon dioxide laser treatment (Lumenis® Ultrapulse® C02 laser with DeepFX™ Yokneam, Israel). There is another arm in the study. 22 subjects with acne will be selected to do the same laser treatment on a localized part of the face (1-3 inflammatory lesions and up to 5 mm adjacent area). We plan to have 22 subjects complete the study on the first arm and 22 on the second arm. Both arms will be treated with the same device and the same energy and density will be used. The first arm will be submitted to 3 laser treatments, with a one-month interval between each treatment appointment and their full face will be treated. The second arm will have only one treatment and only 1-3 lesions will be submitted to the laser treatment.
Interventions
DEVICELaser Intervention
Subjects receive laser treatment.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lesion Count | 3 months | Lesion count is a tally of all different types of blemishes (comedones, papules, pustules, nodules, cysts) on the face. In this study, change in lesion count represents the change in subjects' lesion count post-treatment. A negative change in lesion count indicates that acne improved whereas a positive change in lesion count indicates that acne worsened. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physician's Global Assessment (PGA) Score | 3 months | The Physician's Global Assessment (PGA) score is a clinical scale used by dermatologists to rate the overall severity of acne at a given time. The Acne PGA scales range from 0 to 4 (with 0 being least severe and 4 being most severe). In this study, change in PGA score represents the change in subjects' PGA score following treatment. A negative change in PGA score indicates that acne improved whereas a positive change in PGA score indicates that the acne worsened. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDieter Manstein, MD, PhD
Massachusetts General Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Lesion Count | 28.25 Lesions STANDARD_DEVIATION 16.94 |
| Physician's Global Assessment Score | 4 units on a scale STANDARD_DEVIATION 0 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 0 |
| other Total, other adverse events | 0 / 4 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4 | 0 / 0 |
Outcome results
None listed