Laser Treatment for Acne

Overseen By Lais Clinical Research Coordinator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Oral antibiotics

Disqualifiers: Pregnancy, Keloidal scarring, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of a specific laser treatment for individuals with moderate to severe acne vulgaris, a common skin condition causing pimples and inflammation. Participants will receive laser treatment on acne-affected areas to assess improvements in their skin condition. Ideal candidates are those with significant facial acne who have not found success with standard treatments, such as certain oral medications. As an unphased trial, this study offers participants the chance to contribute to valuable research that could lead to new treatment options for acne.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any oral antibiotics or oral therapy for acne to participate in this trial.

What prior data suggests that this laser treatment is safe for acne?

Research has shown that laser treatments for acne are generally safe and effective for most people. Studies have found that these lasers can reduce acne spots without causing serious side effects. Some individuals might experience mild discomfort or temporary redness, but these effects usually resolve quickly. These treatments are already used for various skin types, supporting their safety. However, multiple sessions may be necessary to see improvement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional acne treatments like topical creams and oral medications, laser treatment directly targets the skin's sebaceous glands and reduces inflammation without the need for ongoing application. This method is unique because it offers a non-invasive approach that may lead to faster and potentially longer-lasting results. Researchers are particularly excited because laser treatment could offer a solution for patients who have not had success with existing options or who experience side effects from topical or oral therapies.

What evidence suggests that this laser treatment is effective for acne?

Research has shown that laser treatment, which participants in this trial will receive, can help reduce acne. One study found a 78% decrease in acne spots after four laser sessions, each a month apart. Another review found that more than half of the patients experienced significant improvement in their acne after 12 weeks. The 650-ms, 1064-nm Nd:YAG laser has proven safe and effective for all skin types, even in severe cases. Overall, laser treatments can significantly reduce acne and enhance skin appearance. ^{1 2 3 4 6}

Who Is on the Research Team?

Dieter Manstein, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-40 with moderate to severe nodular acne (PGA 3 or 4) who haven't responded to standard treatments. Participants must be in good health, willing to avoid sun exposure on treated areas, and not pregnant or breastfeeding. They shouldn't have had laser treatment or isotretinoin therapy recently.

Inclusion Criteria

My gender and skin type do not limit my participation.

In good general health, based on answers provided during the screening visit

Subject must be able to read and understand English;

Exclusion Criteria

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.

I am currently taking medication for acne.

You have had an allergic reaction to numbing creams used for anesthesia in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo laser treatment on their active acne vulgaris lesions

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Laser Intervention

Trial Overview The study tests a commercial laser's effectiveness in treating moderate to severe acne vulgaris. It aims to see if the laser can improve skin condition in those who've declined conventional therapies like oral isotretinoin.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Cutaneous lasers and energy modalities like radiofrequency and ultrasound are generally safe, with rapid healing times and mild, self-resolving side effects such as redness and swelling lasting only hours to days.

While most adverse events are mild, there are some medium- to long-term risks, including changes in skin pigmentation and scarring, but these are rare and can often be managed effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of lasers and light treatments. Alam, M., Warycha, M.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11438631/

Emerging lasers and light-based therapies in the ... Results demonstrated a reduction of at least two grades in IGA severity in 51.7% of patients at week 12, with even higher success rates observed ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S019096222502376X

Light and laser-based therapy in treatment of acne vulgaris In our clinical practice, IPL and PDL both have shown improvement in mild-to-moderate inflammatory acne lesions, but several treatment sessions are required.

3. dermatologytimes.com dermatologytimes.com/view/laser-therapy-gains-ground-in-acne-management

Laser Therapy Gains Ground in Acne Management A recent meta-analysis concluded that multiple PDL treatments can significantly reduce acne severity, particularly noninflammatory lesions.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2884837/

Laser Treatment of Acne Vulgaris - PMC - PubMed Central - NIH After four treatments at 4-week intervals, a 78% reduction in acne lesions and decreased skin oiliness was noted in 25 patients.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.16711

Treatment of Acne Vulgaris With a 650‐ms, 1064‐nm Nd: ... The 650-ms, 1064-nm Nd:YAG laser provides a safe and efficacious treatment of mild to severe acne in patients with white skin and skin of color.

6. jaad.org jaad.org/article/S0190-9622(23)03389-3/fulltext

Guidelines of care for the management of acne vulgaris This guideline presents 18 evidence-based recommendations and 5 good practice statements. Strong recommendations are made for benzoyl ...