The MIRIA Acne Scar Study

Sponsor

AVAVA, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05597267

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Scars - Mixed Atrophic and Hypertrophic	Device: MIRIA Laser	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The MIRIA Acne Scar Study

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment with the MIRIA Laser 3-4 experimental treatments at 4-6 week intervals	Device: MIRIA Laser 4-6 experimental treatments at 4-6 weeks intervals

Arm

Intervention/Treatment

Experimental: Treatment with the MIRIA Laser

3-4 experimental treatments at 4-6 week intervals

Device: MIRIA Laser

4-6 experimental treatments at 4-6 weeks intervals

Outcome Measures

Primary Outcome Measures

Improvement of Facial Acne Scars [3 months after the final treatment, Optional 6 months after final treatment]
A 1 point or greater reduction in facial acne scars severity using the Echelle d'Evaluation Clinique des Cicatrices d'Acne (ECCA) Score, Physician Global Aesthetic Improvement Scale (PGAIS) Score, Subject Global Aesthetic Improvement Scale (SGAIS) Score, as assessed, and agreed upon by at least two of three blinded independent reviewers in at least 70% of subjects as determined with a side-by-side evaluation of baseline and post-treatment photographs. ECCA Global Score Limits: Lowest Score (0) Much Improved, Highest Score (540) No Improvement PGAIS Score Limits: Much Improved (5), Much Worse (1) SGAIS Score Limits: Very Satisfied (6), Very Dissatisfied (1)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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
Significant uncontrolled concurrent illness, such as diabetes mellitus, hypertension, or cardiovascular disease
History of immunosuppression/immune deficiency disorder or currently using immunosuppressive medications
Planned weight loss of greater than five pounds
Facial hair in the treatment areas which would prevent evaluation of the outcome measures. For men, must be clean shaven in the area of treatment
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
Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, is currently breast feeding or planning a pregnancy during the study.
Has had unprotected sun exposure within four weeks of treatment, including the use of tanning beds or plans for unprotected sun exposure during the course of the study,
Has used tanning products, such as creams, lotions and sprays within four weeks prior to treatment.
Coagulation disorder or currently using anti-platelet/anticoagulation medication, including use of aspirin, or fish oil supplements
Taking medications that alter the wound-healing response or evidence of compromised wound healing
Known history of keloid formation
Known history of medical diseases that may cause koebnerization (the appearance of disease in another location), such as vitiligo, psoriasis or lichen planus
History of skin cancer or suspicious lesions in treatment area
Subject is relocating out of the zone of the study site (ie. Moving out of state or about 50+ miles away from study area)
Subject has history or active melasma or other pigmentary disorders such as vitiligo.