MIRIA Laser for Acne Scars

(MIRIA Trial)

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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a laser treatment called the AVAVA MIRIA Laser Skin System to see if it can improve acne scars. People with acne scars will get the laser treatment multiple times. The study will check how well the treatment works over several months.

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 data supports the effectiveness of the MIRIA Laser treatment for acne scars?

Research shows that various types of lasers, including erbium and fractional carbon dioxide lasers, are effective in improving acne scars by reducing redness and improving skin texture. These studies suggest that laser treatments can be a promising option for managing acne scars with minimal side effects. ^{1 2 3 4 5}

Is the MIRIA Laser safe for treating acne scars?

The MIRIA Laser, also known as the Er:YAG laser, has been studied for treating acne scars and is generally considered safe. Some mild side effects like temporary redness and swelling have been reported, but they usually go away on their own within a couple of weeks. ^{2 6 7 8 9}

How does the MIRIA Laser treatment for acne scars differ from other treatments?

The MIRIA Laser treatment is unique because it uses an integrated cooling-vacuum-assisted non-fractional 1540-nm Erbium:Glass laser, which allows for the simultaneous treatment of both acne lesions and scars. This approach promotes collagen remodeling in the skin, improving the appearance of atrophic scars while also addressing active acne lesions, offering a dual benefit not commonly found in other treatments. ^{10 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Safety and Effectiveness of an Automated Microneedling Device in Improving Acne Scarring. [2020]

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

Treatment of atrophic facial acne scars with the Er:YAG laser: a Turkish experience. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Post acne scarring: a review. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Lasers for the treatment of erythema, dyspigmentation, and decreased elasticity in macular acne scars: a systematic review. [2022]

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

Efficacy and safety of a low-energy double-pass 1450-nm diode laser for the treatment of acne scars. [2022]

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

The pinhole method using an erbium: YAG laser for the treatment of papular acne scars. [2018]

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

A randomized split-face, investigator-blinded study of a picosecond Alexandrite laser for post-inflammatory erythema and acne scars. [2021]

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

Ablative non-fractional lasers for atrophic facial acne scars: a new modality of erbium:YAG laser resurfacing in Asians. [2022]

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

Outcomes and adverse effects of ablative vs nonablative lasers for skin resurfacing: A systematic review of 1093 patients. [2021]

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

Treating acne scars in patients with Fitzpatrick skin types IV to VI using the 1450-nm diode laser. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Acne vulgarism treatment using ultra-short laser pulse generated by micro- and nano-ring resonator system. [2015]

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

Integrated Cooling-Vacuum-Assisted Non-Fractional 1540 nm Erbium:Glass Laser is Effective in Treating Acne Scars. [2018]

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

Integrated Cooling-Vacuum-Assisted Non-Fractional 1540-nm Erbium:Glass Laser: A New Modality for the Simultaneous Effective Treatment of Acne Lesions and Scars [2019]

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

Treatment of facial acne scars in Asian skin with the single-spot, 2940-nm Er:YAG dual-mode laser. [2022]