The MIRIA Acne Scar Study

Running, not enrolling · Not applicable

Conditions studied: Acne Scars - Mixed Atrophic and Hypertrophic

In brief

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.

Key facts

Study ID

NCT05597267

Run by

AVAVA, Inc.

People needed

75

Starts

2022-11-04

Expected to finish

2025-02-28

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• Enchantress Dermatology — Miami, Florida, United States
• AVAVA, Inc. — Waltham, Massachusetts, United States
• Laser and Skin Surgery Center of New York — New York, New York, United States

Full record on ClinicalTrials.gov

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