MIRIA Laser for Acne Scars

(MIRIA Trial)

Not currently recruiting at 2 trial locations

Overseen By Zuzel Gascon, APRN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AVAVA, Inc.

Must not be taking: Isotretinoin, Retinoids, Immunosuppressives, others

Disqualifiers: Active acne, Rosacea, Infection, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16-24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser treatment called the MIRIA Laser to evaluate its effectiveness in improving facial acne scars. Participants will receive at least four treatments, scheduled every 4-6 weeks, to monitor changes in scar appearance. The study will assess improvements at 1 month and 3 months, with a possible follow-up at 6 months. It suits individuals aged 18-65 with facial acne scars who can attend regular appointments. As an unphased trial, this study provides participants the chance to access innovative treatment options and contribute to advancing acne scar therapies.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before participating. You must not have taken oral isotretinoin (like Accutane) in the last six months or used topical retinoids in the last 30 days. Additionally, you cannot be on medications that increase sensitivity to sunlight or alter wound healing.

What prior data suggests that the MIRIA Laser is safe for treating acne scars?

Research has shown that the MIRIA Laser is generally safe for treating acne scars. Some studies indicate that it works on all skin types and tones. The FDA has approved the MIRIA Laser for this use, confirming it has passed strict safety tests.

Most people tolerate it well. Mild side effects like redness or swelling may occur, but these usually resolve quickly. Overall, the MIRIA Laser seems to be a safe choice for reducing acne scars. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MIRIA Laser treatment for acne scars because it offers a novel approach compared to traditional methods like topical treatments, chemical peels, or dermabrasion. Unlike these options, the MIRIA Laser uses precise laser technology to target scar tissue directly, potentially promoting collagen production and skin regeneration. This method may result in fewer side effects and a quicker recovery time, making it an appealing option for those looking for effective acne scar treatment.

What evidence suggests that the MIRIA Laser is effective for treating acne scars?

Research shows that the MIRIA Laser, which participants in this trial will receive, can help improve acne scars. In one study, a similar laser treatment improved acne scars by an average of 50.2% for 128 patients. Another study found a 45% reduction in both the size and depth of acne scars after three treatment sessions. The FDA has approved the MIRIA Laser for reducing acne scars, confirming its safety and effectiveness for all skin types. These studies suggest that the MIRIA Laser could be a good option for those looking to reduce acne scars. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-65 with facial acne scars who can follow the study procedures and provide informed consent. Excluded are those with light-triggered seizure disorders, recent significant sun exposure, active infections or wounds on the face, skin cancer history in treatment area, recent use of certain skin treatments like retinoids or tanning products, ongoing participation in other clinical trials affecting the face, pregnancy or breastfeeding women without effective birth control.

Inclusion Criteria

Able and willing to comply with all study procedures and at home care; and,

Able and willing to give informed consent.

Able and willing to give informed consent

Exclusion Criteria

You plan to lose more than five pounds.

Any condition or situation which, in the investigators opinion, may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation

I do not have facial hair that could interfere with treatment assessments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MIRIA laser treatment at least 4 times with each treatment spaced 4-6 weeks apart

16-24 weeks

4 visits (in-person)

Follow-up

Participants are monitored for improvement of acne scars at 1 month and 3 months after the final treatment

3 months

Optional Long-term Follow-up

Participants may be evaluated for improvement of acne scars at 6 months after the final treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• MIRIA Laser

Trial Overview The MIRIA Acne Scar Study tests the AVAVA MIRIA Laser Skin System's effectiveness on treating acne scars. Participants will undergo at least four laser treatments spaced 4-6 weeks apart. The improvement of their acne scars will be assessed after one month and could extend to three or six months post-treatment.

How Is the Trial Designed?

Group I: Treatment with the MIRIA Laser Experimental Treatment 1 Intervention

3-4 experimental treatments at 4-6 week intervals

Who Is Running the Clinical Trial?

AVAVA, Inc.

Lead Sponsor

Trials

4

Recruited

500+

Published Research Related to This Trial

The Er:YAG laser treatment for acne scars showed a significant average clinical improvement of 50.2% in 128 patients aged 22-42, indicating its efficacy in enhancing skin texture and reducing scarring.

The treatment was found to be safe, with most side effects being mild and temporary; however, some patients experienced prolonged erythema and post-inflammatory hyperpigmentation, which occurred in 7% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of atrophic facial acne scars with the Er:YAG laser: a Turkish experience. Kutlubay, Z., Gokdemir, G.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05597267

Study Details | NCT05597267 | The MIRIA Acne Scar Study This study is being conducted to evaluate the performance and efficacy of the AVAVA MIRIA Laser Skin System treatment on acne scars.

2. withpower.com withpower.com/trial/phase-acne-vulgaris-10-2022-929fb

MIRIA Laser for Acne Scars · Info for Participants Published Research Related to This Trial ... The Er:YAG laser treatment for acne scars showed a significant average clinical improvement of 50.2% in 128 patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11911818/

Effectiveness and Safety of the Use of 1470 nm Laser Therapy ... The three laser therapy sessions using the tested device resulted in an average reduction of 45% in both diameter and depth of acne scars 28 ...

4. withpower.com withpower.com/trial/miria-skin-treatment-for-wrinkles-and-scars-d5e4a

MIRIA Skin Treatment for Wrinkles and Scars This non-significant risk study is intended to demonstrate the use of the MIRIA Skin Treatment System can show improvement in dermatologic conditions ...

5. avavaskin.com avavaskin.com/news/avava-laser-receives-fda-approval-for-acne-scarring-for-all-skin-types/

AVAVA Laser Receives FDA Approval for Acne Scarring for ... To test MIRIA for safe and effective acne scarring reduction across all Fitzpatrick scale skin tones, AVAVA conducted a study with 47 ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf25/K250402.pdf

April 14, 2025 Avava Inc Richard Bankowski Executive VP of ... Overall, the MIRIA Laser was found to be safe and effective for the treatment of Acne Scars in. Fitzpatrick Skin Types I – VI. Conclusion. The ...

7. pfrankmd.com pfrankmd.com/procedure/skin-tightening/miria/

MIRIA™ Skin Tightening | PFRANKMD by Dr. Paul Jarrod ... MIRIA is the only FDA-cleared laser that more than doubles the current therapeutic energy dose, delivering up to 150mj of conical energy to the dermis while ...

8. newbeauty.com newbeauty.com/miria-laser-fda-approved-for-acne-scarring/

MIRIA Laser Earns FDA Approval for Acne Scarring MIRIA by AVAVA Is FDA-Approved for Treating Acne Scars on All Skin Types and Tones. Laser use on darker skin tones has been a tricky topic for ...