MIRIA Skin Treatment for Wrinkles and Scars

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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This non-significant risk study is intended to demonstrate the use of the MIRIA Skin Treatment System can show improvement in dermatologic conditions currently indicated for treatment with a laser (such as, but not limited to, benign pigmented lesions, benign cutaneous lesions, wrinkles, textural irregularities, or scars). The study is also intended to assist in determination of the optimal laser configuration and treatment parameters that most consistently yield results.

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 data supports the effectiveness of the MIRIA treatment for wrinkles and scars?

Research shows that microneedling, a component of the MIRIA treatment, significantly improves wrinkles, skin texture, and scars with minimal side effects. Studies have demonstrated its effectiveness in reducing wrinkles and improving scar appearance, making it a promising option for skin rejuvenation. ^{1 2 3 4 5}

Is the MIRIA Skin Treatment for Wrinkles and Scars safe for humans?

The safety of microneedles, which may be related to MIRIA, is still being studied, but they are widely used in cosmetics. Some adverse effects like skin reactions and infections have been reported with similar products. It's important to be aware of potential side effects and consult with a healthcare provider. ^{6 7 8 9 10}

How does the MIRIA treatment for wrinkles and scars differ from other treatments?

The MIRIA treatment is unique because it uses tanshinone IIA, a compound from the plant Salvia miltiorrhiza, delivered through self-soluble microneedles to enhance skin retention and target thickened skin layers, which is different from traditional methods like lasers or creams. ^{1 11 12 13 14}

Research Team

Hyemin Pomerantz, MD

Principal Investigator

AVAVA, Inc.

Eligibility Criteria

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.

I haven't used artificial tanning on target areas in the last month and don't plan to during the study.

History of connective tissue disease, such as lupus or scleroderma

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

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

Safety and Effectiveness of an Automated Microneedling Device in Improving the Signs of Aging Skin. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Comparative analysis of effects induced by hyaluronic acid and its combined formula on skin functional parameters in second-degree photoaging. [2021]

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

Improving the Appearance of Surgical Facial Scars With IncobotulinumtoxinA and Microneedling. [2021]

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

Microneedling with topical vitamin C versus microneedling with topical insulin in the treatment of atrophic post-acne scars: A split-face study. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Microneedling: Where do we stand now? A systematic review of the literature. [2018]

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

Dermatotoxicology of microneedles (MNs) in man. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

[Survey of incidents associated with injectable dermal fillers reported to the German Medical Devices Vigilance System]. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Adverse effects of cosmetics and toiletries reported to the Swedish Medical Products Agency 1989-1994. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrates no evidence of a health risk from developmental toxicity. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Notification of undesirable effects of cosmetics and toiletries. [2015]

11. Singapore pubmed.ncbi.nlm.nih.gov

Preparation of tanshinone IIA self-soluble microneedles and its inhibition on proliferation of human skin fibroblasts. [2023]

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

The Effects of a Standardized Extract of Centella asiatica on Postlaser Resurfacing Wound Healing on the Face: A Split-Face, Double-Blind, Randomized, Placebo-Controlled Trial. [2021]

13. England pubmed.ncbi.nlm.nih.gov

A prospective study of the safety and efficacy of a combined bipolar radiofrequency, intense pulsed light, and infrared diode laser treatment for global facial photoaging. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of picosecond laser for wrinkle in Indonesian skin. [2022]