MIRIA Skin Treatment for Wrinkles and Scars

Not currently recruiting at 1 trial location

Overseen By Marina I. Peredo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AVAVA, Inc.

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

Disqualifiers: Vitiligo, Psoriasis, Eczema, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12-24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the MIRIA Skin Treatment System, a laser therapy designed to improve skin conditions such as wrinkles, scars, and benign lesions. Researchers seek to determine the optimal laser settings for consistently enhancing these skin issues. This trial may suit individuals with skin conditions treatable by lasers or those willing to have the laser tested on normal skin. Participants must adhere to specific skincare guidelines and consent to having their skin photographed for research purposes. As an unphased trial, this study allows participants to contribute to pioneering research in laser skin treatments.

Do I need to stop taking my current medications for the trial?

You may need to stop certain medications, like systemic and topical corticosteroids, retinoids, or prescription skin-lightening medications, based on the investigator's discretion. If you are on systemic treatments like oral isotretinoin, you must have stopped them at least 6 months before joining the trial.

What prior data suggests that the MIRIA Skin Treatment System is safe for dermatologic conditions?

Research has shown that the MIRIA Skin Treatment is generally safe. In a previous study, all participants tolerated the treatment well, with an average pain score of 4.4 out of 10, indicating mild discomfort. Another study found that microneedling, a component of the MIRIA treatment, can improve wrinkles, skin texture, and scars with few side effects. This treatment is also safe for all skin types and tones, making it suitable for many individuals. Overall, the MIRIA Laser appears to be a safe option for addressing skin issues like wrinkles and scars. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MIRIA Skin Treatment for wrinkles and scars because it uses an innovative laser technology that precisely targets and refines skin imperfections. Unlike traditional treatments like chemical peels or dermabrasion, which can be invasive and require significant recovery time, the MIRIA Laser offers a non-invasive approach with potentially quicker recovery. Additionally, the treatment's precision allows for customized care, adjusting to the specific needs of each patient's skin, which could lead to more effective and tailored results.

What evidence suggests that the MIRIA Skin Treatment is effective for wrinkles and scars?

Studies have shown that the MIRIA Laser effectively reduces wrinkles and improves the appearance of scars. Research indicates that this treatment smooths the skin and reduces signs of aging. It also promotes healthier skin, which can lessen acne scars. Unlike some other treatments, MIRIA resurfaces and tightens the skin with minimal recovery time, making it a promising option for those seeking to refresh their skin. ^{2 3 5 6 7}

Who Is on the Research Team?

Hyemin Pomerantz, MD

Principal Investigator

AVAVA, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with skin conditions like Cutis Laxa, acne scars, pigmented lesions, loose skin, scarring, and wrinkles. Participants should be seeking improvement in these areas using the MIRIA Skin Treatment System.

Inclusion Criteria

Willingness to have multiple areas exposed

Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes

I need laser treatment for a skin condition or for assessing normal skin.

Exclusion Criteria

I have used topical treatment on the affected area in the last month.

History of connective tissue disease, such as lupus or scleroderma

I do not have uncontrolled illnesses like diabetes or heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants may use topical cream or lotion for up to 1 month prior to the laser procedure

4 weeks

Treatment

Participants receive 3-4 experimental treatments with the MIRIA Laser at 4-6 week intervals

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Extended Follow-up

Participants continue to be monitored for up to 18 months to assess long-term outcomes

15 months

What Are the Treatments Tested in This Trial?

Interventions

• MIRIA

Trial Overview The AVAVA MIRIA Pilot Study is testing the effectiveness of the MIRIA Skin Treatment System on various dermatologic conditions that are typically treated with lasers. The study aims to find the best laser settings and treatment methods.

How Is the Trial Designed?

Group I: Treated Cohort Experimental Treatment 1 Intervention

Experimental: Treatment with the MIRIA Laser 3-4 experimental treatments at 4-6 week intervals. Refine usage of device

Who Is Running the Clinical Trial?

AVAVA, Inc.

Lead Sponsor

Trials

4

Recruited

500+

Published Research Related to This Trial

Microneedles (MNs) have gained popularity in cosmetics, but their safety profile is still being established as the FDA begins to regulate these devices.

Current literature indicates that while MNs are widely used, there is a need for more research to fully understand potential adverse effects, such as infections and skin reactions, associated with their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermatotoxicology of microneedles (MNs) in man. Cary, JH., Li, BS., Maibach, HI.[2020]

A pilot project to collect reports of undesirable effects (UEs) from cosmetic products revealed that dermatologists were the primary reporters, submitting 47 out of 76 total reports, highlighting the need for better reporting systems in cosmetovigilance.

The majority of reported UEs were cutaneous reactions, with allergic contact dermatitis and irritant contact dermatitis being the most common diagnoses, indicating that facial and body care products are significant contributors to these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notification of undesirable effects of cosmetics and toiletries. Sportiello, L., Cammarota, S., de Portu, S., et al.[2015]

A total of 136 incident reports related to dermal fillers were analyzed, involving 143 patients, with the most common issue being the formation of nodules in 89 cases.

Most incidents required either conservative or surgical treatment, highlighting the need for careful monitoring and potential corrective actions for dermal filler products under German medical device regulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Survey of incidents associated with injectable dermal fillers reported to the German Medical Devices Vigilance System]. Heinz, BC., Ladhoff, U., Kahl, Ch., et al.[2016]

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/miria-skin-treatment-for-wrinkles-and-scars-d5e4a

MIRIA Skin Treatment for Wrinkles and Scars Studies have demonstrated its effectiveness in reducing wrinkles and improving scar appearance, making it a promising option for skin rejuvenation.

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

MIRIA™ Skin Tightening | PFRANKMD by Dr. Paul Jarrod ... – Improvement of Fine Lines and Wrinkles: Smoothens skin and reduces signs of aging. – Reduction of Acne Scarring: Promotes healthier skin tissue regeneration.

4. joleneedgar.substack.com joleneedgar.substack.com/p/can-miria-really-resurface-tighten

Can Miria Really Resurface, Tighten & Plump the Skin? Miria not only resurfaces but also tightens, similar to devices like Ulthera, Sofwave, and Thermage, while restoring lost volume.

5. unionderm.com unionderm.com/treatment/miria/

Miria by Avava | Skin Resurfacing & Rejuvenation Laser Since the skin surface remains largely intact with MIRIA laser resurfacing, downtime is minimal—often no more than a few days.

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

April 14, 2025 Avava Inc Richard Bankowski Executive VP of ... Treatment was well tolerated by all subjects with an average pain score of 4.4/10. Overall, the MIRIA Laser was found to be safe and effective ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223871.pdf

June 22, 2023 Avava, Inc. Jay Bhawalkar, Phd Chief ... The data show that the MIRIA Skin. Treatment System performs in accordance with its specifications and requirements for both safety and ...