Acne VulgarisNCT04466527
Laser Treatment of Moderate to Severe Acne Vulgaris
A study testing Laser Intervention in people with Acne Vulgaris, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Laser Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
- Willing to sun protect treated area for the duration of enrollment in the study and 1 year after treatment;
- Subjects must be ineligible for or have declined standard of care treatments (e.g. oral isotretinoin therapy).
Who cannot join
- Participation in another investigational drug or device clinical trial in the past 30 days;
- Currently undergoing or wish to begin or continue topical treatments;
- Are pregnant or lactating;
- History of allergic reaction to topical anesthesia;
- Subjects may not have undergone oral isotretinoin therapy within the past 12 months;
- Currently take oral antibiotic or oral therapy for acne;
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- History of keloidal or hypertrophic scarring;
- Laser treatment in past six months;
- History of poor wound healing;
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Clinical Unit for Research Trials & Outcomes in Skin
Boston, Massachusetts, 02114
About this study
Official title: Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial
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:
Read more
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
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Laser Intervention
- Keywords
- Acne, Acne Vulgaris, Laser, Cystic Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser InterventionDevice
Subjects receive laser treatment.
| Study group | Role | What they receive |
|---|---|---|
| Full-face treatment | Experimental | 3 laser sessions (whole face), up to 22 subjects Receives: Device: Laser Intervention |
| Localized treatment | Experimental | 1 laser session on 1-3 selected lesions, up to 22 subjects Receives: Device: Laser Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lesion Count
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.
Measured: 3 months
Secondary outcomes (1)
Change in Physician's Global Assessment (PGA) Score
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start9 Nov 2020
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Why it stopped: Arm 2 (focal/localized treatment of 1-3 lesions, single treatment) was not initiated as resources and recruitment were prioritized for Arm 1.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Manstein, MD, Massachusetts General Hospital
- Investigators
- Dieter Manstein, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466527
- Sponsor's protocol ID
- 2020P000838
- Status last verified
- May 2026
- First submitted
- 2 Jul 2020
- Last updated
- 1 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial
- ClinicalTrials.gov ID
- NCT04466527
- Acronym / sponsor ID
- 2020P000838
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Acne Vulgaris, Laser, Cystic Acne
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Arm 2 (focal/localized treatment of 1-3 lesions, single treatment) was not initiated as resources and recruitment were prioritized for Arm 1.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Posted 1 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-face treatment | Experimental | Device: Laser Intervention3 laser sessions (whole face), up to 22 subjects |
| Localized treatment | Experimental | Device: Laser Intervention1 laser session on 1-3 selected lesions, up to 22 subjects |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- Participation in another investigational drug or device clinical trial in the past 30 days;
- Currently undergoing or wish to begin or continue topical treatments;
- Are pregnant or lactating;
- History of allergic reaction to topical anesthesia;
- Subjects may not have undergone oral isotretinoin therapy within the past 12 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser InterventionSubjects receive laser treatment. | Device | Full-face treatment, Localized treatment |
Primary outcome
Change in Lesion Count
Time frame: 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.
1 secondary outcome
Change in Physician's Global Assessment (PGA) Score
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Manstein, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Intervention in people with Acne Vulgaris, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lesion Count (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.