AVAVA for Acne

Overseen By Alexander Denis

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: 4

Duration: Immediate Post-Treatment

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of a new device, called AVAVA, for treating various skin conditions. The researchers seek feedback from participants to understand their experience with the treatment. They also aim to observe improvements in skin conditions such as acne, scars, or wrinkles and monitor any side effects. This trial may suit individuals with active acne or acne scars who are open to having their treatment area photographed. Participants must live within 50 miles of the study site and agree to follow specific skincare and sun exposure guidelines. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially benefit from a novel treatment approach.

Will I have to stop taking my current medications?

You may need to stop using certain medications, like systemic or topical corticosteroids and prescription skin-lightening medications, on the treated areas. The decision will be made by the study investigator. If you're taking medications that increase sensitivity to light, you might need to stop those as well.

What prior data suggests that the AVAVA device is safe for treating dermatologic conditions?

Research has shown that the AVAVA device is safe for all skin types, particularly in treating acne scars. A previous study found the device effective and easy to tolerate. The FDA has approved AVAVA's technology for treating acne scars, confirming its safety. While ongoing studies aim to further validate its safety and effectiveness, current evidence supports the AVAVA device as a safe option for skin treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for acne, such as topical creams and oral antibiotics, AVAVA uses a device-based approach to target the condition. This new method is non-invasive and aims to directly address acne at its source without the side effects commonly associated with traditional medications. Researchers are excited because AVAVA's device could offer a more targeted and potentially faster way to reduce acne, providing a novel alternative for those who haven't found success with existing options.

What evidence suggests that the AVAVA device is effective for acne?

Research has shown that the AVAVA device effectively treats acne scars. In one study, over 90% of participants saw visible improvement, with half experiencing at least a 50% reduction in their scars. The device uses Focal Point Technology to deliver energy precisely to the skin, making it safer for darker skin tones compared to traditional lasers. Overall, users report high satisfaction with the AVAVA device, and many are willing to recommend it to others. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with various skin conditions such as acne, scarring, wrinkles, pigmented lesions, and skin texture disorders. It's also open to those with pulmonary artery hypertrophy. Specific eligibility criteria are not provided.

Inclusion Criteria

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

I am willing to shave my hair in the area to be treated.

I am willing to follow a skin care plan, limit sun exposure, and avoid certain medications and procedures on treated areas.

Exclusion Criteria

I have an infection or an open wound in the area that needs treatment.

I have a connective tissue disease like lupus or scleroderma.

I haven't had surgery in the target area in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects treated with the AVAVA Device for dermatologic conditions

Immediate Post-Treatment

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 visits (in-person) at 3, 6, and 12 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• AVAVA

Trial Overview

The AVAVA device is being tested on patients with different dermatologic issues. The main goal is to gather patient feedback through questionnaires about their experience using the device.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Subjects treated with the AVAVA Device

Who Is Running the Clinical Trial?

AVAVA, Inc.

Lead Sponsor

Trials

4

Recruited

500+

Citations

1.

dermatologytimes.com

dermatologytimes.com/view/next-gen-avava-platform-cleared-by-fda-for-wrinkle-reduction-across-all-skin-types

Next-Gen AVAVA Platform Cleared by FDA for Wrinkle ...

Results revealed exceptionally high satisfaction: 100% of patients indicated willingness to undergo another treatment and recommend AVAVA to ...

2.

practicaldermatology.com

practicaldermatology.com/news/avava-receives-fda-clearance-for-acne-scar-treatment-on-all-skin-types-using-focal-point-technology/2474319/

AVAVA Receives FDA Clearance for Acne Scar Treatment ...

Independent dermatologists evaluating the results reported that more than 90% of participants showed visible improvement, including a median 50% ...

3.

avavaskin.com

avavaskin.com/news/dermatology-times-jaad-study-validates-avavas-precision-laser-innovation/

JAAD Study Validate's AVAVA's Precision Laser Innovation

Avava's Focal Point Technology delivers precise energy to skin depths, reducing risks for darker skin tones compared to traditional lasers.

4.

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.

5.

withpower.com

withpower.com/trial/phase-acne-8-2024-cce51

AVAVA for Acne

Primary outcome is the collection and analysis of patient questionnaires related to the overall experience of the device treatment. Secondary outcome measures ...

6.

accessdata.fda.gov

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

April 14, 2025 Avava Inc Richard Bankowski Executive VP of ...

new indication for use of the treatment of acne scars showed that the device is both effective and safe to use on all skin types. Thus, the ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf21/K213726.pdf

June 28, 2022 Avava, Inc Jay Bhawalkar Chief Technology ...

The PL-1 Skin Treatment System is as safe and effective as the predicate devices operating in the 1064 Q-switched nanosecond mode with a ...

8.

jaad.org

jaad.org/article/S0190-9622(24)02809-3/fulltext

Controlling treatment depth and pattern of skin injury by a ...

Clinical data are currently being collected to further explore the safety and efficacy of the device. Conclusion. The 1550 nm laser with ...

9.

dermatologytimes.com

dermatologytimes.com/view/jaad-study-validates-avava-s-precision-laser-innovation

JAAD Study Validates Avava's Precision Laser Innovation

AvavaSync digital platform enhances treatment management, offering real-time data and streamlined workflows for personalized care. The ...