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

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is laser treatment for acne safe?

Laser treatments for acne are generally safe when used properly, with most side effects being mild and temporary, such as redness and swelling. However, there can be more serious but rare complications like scarring or skin color changes, and it's important for practitioners to be aware of these potential risks. ^{1 2 3 4 5}

How is the Laser Intervention treatment for acne different from other treatments?

The Laser Intervention treatment for acne uses a 1,450 nm diode laser with a new double-pass protocol and a larger treatment beam, which reduces pain and treatment time compared to traditional laser methods. This makes it more comfortable and efficient for patients, especially younger ones, compared to other laser treatments. ^{1 6 7 8 9}

What data supports the effectiveness of the laser treatment for acne?

Research shows that various types of laser treatments, including the 1,450 nm diode laser and the 577-nm high-power laser, have been effective in improving acne and acne scars. These treatments are considered safe and effective when used properly, providing a good option for managing active acne lesions. ^{1 5 6 10 11}

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. United States pubmed.ncbi.nlm.nih.gov

Double-pass, low-fluence laser treatment using a large spot-size 1,450 nm laser improves acne. [2009]

2. China pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of 585 nm Q-switched laser treatment on inflammatory lesion and postinflammatory erythema of acne vulgaris]. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Intense Pulsed light Versus 1,064 Long-Pulsed Neodymium: Yttrium-Aluminum- Garnet Laser in the Treatment of Facial Acne Vulgaris. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of CO2 laser therapy in treating acne depressed scar: A protocol of systematic review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

577-nm high-power optically pumped semiconductor laser is safe and effective in the treatment of inflammatory acne: a prospective, single-center, split-face comparative study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events associated with nonablative cutaneous laser, radiofrequency, and light-based devices. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

The use of the low-fluence 1064 nm Nd:YAG laser in a female with contraindications to systemic anti-acne therapy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Complications of lasers and light treatments. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy of Red or Infrared Light-Emitting Diodes in a Mouse Model of Propionibacterium acnes-Induced Inflammation. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Current treatments of acne: Medications, lights, lasers, and a novel 650-μs 1064-nm Nd: YAG laser. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

A pilot investigation comparing low-energy, double pass 1,450 nm laser treatment of acne to conventional single-pass, high-energy treatment. [2015]