What side effects are associated with this type of intervention?

Common side effects of laser therapies for acne scars, such as those used in the AVAVA MIRIA Laser Skin System, include erythema (redness), edema (swelling), and transient hyperpigmentation or hypopigmentation. Patients may also experience discomfort or pain during the procedure, which can be managed with topical anesthetics. Post-treatment, there is a risk of infection if the skin is not properly cared for. Less commonly, scarring and prolonged changes in skin texture or color can occur. It is essential to follow post-procedure care instructions to minimize these risks.

What prior FDA approvals exist?

The provided context does not specify prior FDA approvals for treatments specifically targeting acne scars. However, it does mention the use of laser resurfacing and other laser-based therapies for skin rejuvenation and acne scar treatment. These treatments, such as the AVAVA MIRIA Laser Skin System, typically involve the use of lasers to promote collagen remodeling and improve skin texture. While specific FDA approvals for these laser systems are not detailed, laser therapy remains a common and effective approach for managing acne scars.

What other types of research exist?

Promising alternatives to the AVAVA MIRIA Laser Skin System for acne scars include: 1) 2940-nm erbium:YAG laser with Spatially Modulated Ablation™, which has shown efficacy and safety in facial rejuvenation. 2) Picosecond alexandrite laser with a specialized lens array, which has demonstrated effectiveness in treating facial photoaging. 3) Nonablative infrared lasers (1000-1800 nm) that penetrate deeply and exert effects in the reticular dermis, useful for skin laxity and potentially acne scars.

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Laser Therapy

MIRIA Laser for Acne Scars (MIRIA Trial)

N/A

Recruiting

Research Sponsored by AVAVA, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects 18-65 years of age

Be older than 18 years old

Must not have

Facial hair in the treatment areas which would prevent evaluation of the outcome measures

Seizure disorder triggered by light

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after the final treatment, optional 6 months after final treatment

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the MIRIA laser treatment may include temporary redness, swelling at the treatment site, increased sensitivity to sunlight, changes in pigmentation such as lightening or darkening of skin areas treated by the laser and a risk of triggering herpes simplex if previously affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have seizures triggered by light.

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I have not been exposed to the sun without protection or used a tanning bed in the last four weeks.

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I do not have any infections, open wounds, or abscesses in the area being treated.

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I have had skin cancer or suspicious skin lesions in the area to be treated.

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I have active acne or rosacea.

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I am taking blood thinners or supplements like aspirin or fish oil.

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I have taken Accutane or similar medication in the past 6 months.

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I have been treated with gold therapy.

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I am taking medication that makes my skin more sensitive to sunlight.

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I have an immune system disorder or am taking medication that weakens my immune system.

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I am on medication that affects how my wounds heal.

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I do not have any major inflammatory diseases like lupus.

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I have had herpes simplex in the area to be treated.

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I have a history of skin color changes, like melasma or vitiligo.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after the final treatment, optional 6 months after final treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after the final treatment, optional 6 months after final treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after the final treatment, optional 6 months after final treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement of Facial Acne Scars

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with the MIRIA LaserExperimental Treatment1 Intervention

3-4 experimental treatments at 4-6 week intervals

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for acne scars include laser therapy, chemical peels, and microneedling. Laser therapy, such as the AVAVA MIRIA Laser Skin System, works by targeting the skin's deeper layers to stimulate collagen production and promote skin resurfacing. This process helps to remodel the skin's structure, reducing the appearance of scars. Chemical peels use acids to exfoliate the top layers of skin, encouraging new skin growth and improving texture. Microneedling involves creating tiny punctures in the skin to trigger the body's natural healing response, also boosting collagen production. These treatments are crucial for acne scar patients as they address the underlying skin damage, leading to smoother, more even skin and improved self-esteem.

Laser resurfacing of the skin for the improvement of facial acne scarring: a systematic review of the evidence.