The MIRIA Acne Scar Study

NCT05597267 | Active Not Recruiting FDA Device

• 1 other identifier: AV-22-002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

This study is being conducted to evaluate the performance and efficacy of the AVAVA MIRIA Laser Skin System treatment on acne scars. Participants will be treated with the MIRIA laser at least 4 times with each treatment spaced 4-6 weeks apart. The improvement of acne scars will be evaluated at 1 month and 3 months with a possibility of 6 months evaluation after the fourth treatment.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Keywords

Laser Treatment; Acne Scars; MIRIA Laser; Laser; AVAVA; All Skin Types; Scars

Outcome Measures

Primary Outcomes (1)

• ECCA (échelle d'évaluation clinique des cicatrices d'acné) Grading

  A 1 point or greater reduction in facial acne scars severity using the Echelle d'Evaluation Clinique des Cicatrices d'Acne (ECCA) Score ECCA Global Score Limits: Lowest Score (0) to Highest Score (540)

  3 months after the final treatment, Optional 6 months after final treatment

Secondary Outcomes (3)

• Blinded Evaluation of Treatment Imaging

  From enrollment up to3 months after the final treatment, Optional up to 6 months after final treatment

• Physician Global Aesthetic Improvement Scale Scoring

  Up to 3 months after the final treatment, Optional up to 6 months after final treatment

• Treatment Pain Assessment

  Through study completion, an average of 12 months

Study Arms (1)

Treatment with the MIRIA Laser

EXPERIMENTAL

3-4 experimental treatments at 4-6 week intervals

Device: MIRIA Laser

Interventions

MIRIA Laser DEVICE

4-6 experimental treatments at 4-6 weeks intervals

Treatment with the MIRIA Laser

Eligibility Criteria

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

You may qualify if:

• Subjects 18-65 years of age
• Acne scars on the face
• Able and willing to comply with all study procedures and at home care; and,
• Able and willing to give informed consent.

You may not qualify if:

• Hypersensitive to light in the near infrared wavelength region
• On medication known to increase sensitivity to sunlight
• Seizure disorder triggered by light
• Takes or has taken oral isotretinoin, such as Accutane®, within the last six months
• Use of topical over the counter or prescription retinoids such as Retinol creams, gels, Tazarotene, Tretinoin, Adapalene, within the last 30 days
• Active acne or rosacea
• Active localized or systemic infection, or an open wound or abscess in area being treated
• Significant systemic inflammatory disease or illness, such as lupus, or an illness localized in area being treated
• Common acquired nevi that are predisposed to the development of malignant melanoma
• Current or prior herpes simplex in the target treatment area
• Is receiving or has received gold therapy
• Currently enrolled in an investigational drug or device trial, or has received an investigational drug or was treated with an investigational device within in the area to be treated 6 months prior to study entry
• Facial cosmetic procedures in the target areas within previous 6 months (e.g., laser or other energy-based device treatment, microdermabrasion, injection of dermal filler)
• Micro-needling and/or chemical peel on the target treatment area in the past 3 months
• Injection of cosmetic neurotoxins such as botulinum toxin in the treatment areas within the previous 3 months of standard duration toxins, and 6 months for long lasting neurotoxin therapy

Sponsors & Collaborators

• AVAVA, Inc.: lead

Study Sites (3)

Enchantress Dermatology

Miami, Florida, 33173, United States

Location

AVAVA, Inc.

Waltham, Massachusetts, 02451, United States

Location

Laser and Skin Surgery Center of New York

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Hypertrophy; Cicatrix

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

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: October 24, 2022
• First Posted: October 28, 2022
• Study Start: November 4, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)