AVAVA MIRIA General Use

NCT06868615 | Recruiting FDA Device

• 1 other identifier: AV-24-003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A general protocol to treat a variety of dermatologic conditions and collect patient feedback. Primary outcome is the collection and analysis of patient questionnaires related to the overall experience of the device treatment. Secondary outcome measures include physician and subject evaluations in regards to improvement seen in the device as well as assessment of side effects.

Conditions

Acne; Acne Scars - Mixed Atrophic and Hypertrophic; Scars; Wrinkle; Pigment; Lesion; Skin Texture Disorder

Outcome Measures

Primary Outcomes (1)

• Completion of Post-Treatment Subject Questionnaire

  Post-treatment questionnaire to evaluate the overall patient experience including descriptions of the treatment session and overall patient experience.

  Immediate Post-Treatment

Secondary Outcomes (6)

• Blinded Assessment of Before and After Imaging by Trained Dermatologist

  Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment

• Completion of Follow-Up Subject Questionnaire

  3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment

• Physician Rated Satisfaction

  Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment

• Subject Rated Satisfaction

  Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment

• Physician Rated Global Clinical Aesthetic Improvement Scale Scoring

  Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment

Study Arms (1)

Intervention

EXPERIMENTAL

Subjects treated with the AVAVA Device

Device: AVAVA

Interventions

AVAVA DEVICE

1550nm Non-Ablative Fractional Laser

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 to 70 years of age.
• Dermatologic condition that can be addressed by the laser, including but not limited to:
• Wrinkles
• Scars
• Acne Scars
• Active Acne
• Dyschromia
• Cutaneous Lesions such as Age or Sun Spots
• Melasma
• Laxity
• Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes.
• Willingness to comply with the following during the study, including the follow-up period:
• maintain consistent skin care regimen on treated areas.
• cover treated areas or have very limited sun exposure and, if requested, use an approved sunscreen of SPF 50 or higher.
• refrain from using systemic corticosteroids, according to Investigator discretion.

You may not qualify if:

• Skin pathology or condition that could interfere with evaluation of the study procedure, e.g.,
• Systemic treatment prescribed within previous 6 months (e.g., oral medication such as isotretinoin)
• Surgical treatment in the target areas within previous 6 months (e.g., laser surgery)
• Active vitiligo, psoriasis, or eczema in the treatment area
• Injection of dermal filler in the target areas within previous 1 month (e.g., collagen, hyaluronic acid filler)
• Cosmetic procedures in the target areas within prior 3 months (e.g., laser, microdermabrasion, skin peel)
• Topical treatment applied to target areas within the previous 1 month or according to Investigator discretion.
• Active suntan and unable or unlikely to refrain from tanning within the follow-up period.
• Artificial tanning in the target areas within the previous 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period.
• Active localized or systemic infection, or an open wound in area being treated.
• Lesions in the treatment areas suspicious for malignancy (skin cancer, melanoma)
• History of abnormal wound healing or abnormal scarring (e.g., hypertrophic or keloid)
• History of connective tissue disease, such as lupus or scleroderma.
• Any use of medication that is known to increase sensitivity to light according to Investigator's discretion (e.g., topicals that produce sensitivity to light may be used in areas other than the target area).
• History of gold therapy.

Sponsors & Collaborators

• AVAVA, Inc.: lead

Study Sites (1)

AVAVA, Inc.

Waltham, Massachusetts, 02451, United States

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris; Hypertrophy; Cicatrix

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Central Study Contacts

Alexander Denis

CONTACT

6176936669; studies@avavaskin.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: September 11, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)