The MIRIA Acne Scar Study

Last updated: March 5, 2025
Sponsor: AVAVA, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Inflammatory Comedones

Scar Tissue

Acne

Treatment

MIRIA Laser

Clinical Study ID

NCT05597267
AV-22-002
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 beingtreated

  • Significant systemic inflammatory disease or illness, such as lupus, or an illnesslocalized 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 aninvestigational drug or was treated with an investigational device within in thearea to be treated 6 months prior to study entry

  • Facial cosmetic procedures in the target areas within previous 6 months (e.g., laseror other energy-based device treatment, microdermabrasion, injection of dermalfiller)

  • Micro-needling and/or chemical peel on the target treatment area in the past 3months

  • Injection of cosmetic neurotoxins such as botulinum toxin in the treatment areaswithin the previous 3 months of standard duration toxins, and 6 months for longlasting neurotoxin therapy

  • Significant uncontrolled concurrent illness, such as diabetes mellitus,hypertension, or cardiovascular disease

  • History of immunosuppression/immune deficiency disorder or currently usingimmunosuppressive medications

  • Planned weight loss of greater than five pounds

  • Facial hair in the treatment areas which would prevent evaluation of the outcomemeasures. For men, must be clean shaven in the area of treatment

  • Any condition or situation which, in the investigators opinion, may put the subjectat significant risk, may confound study results or may interfere significantly withthe subject's participation

  • Is pregnant or of childbearing potential and not using medically effective birthcontrol, or has been pregnant in the last 3 months, is currently breast feeding orplanning a pregnancy during the study.

  • Has had unprotected sun exposure within four weeks of treatment, including the useof tanning beds or plans for unprotected sun exposure during the course of thestudy,

  • Has used tanning products, such as creams, lotions and sprays within four weeksprior 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 compromisedwound healing

  • Known history of keloid formation

  • Known history of medical diseases that may cause koebnerization (the appearance ofdisease 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 orabout 50+ miles away from study area)

  • Subject has history or active melasma or other pigmentary disorders such asvitiligo.

Study Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: MIRIA Laser
Phase:
Study Start date:
November 04, 2022
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • Enchantress Dermatology

    Miami, Florida 33173
    United States

    Site Not Available

  • AVAVA, Inc.

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Laser and Skin Surgery Center of New York

    New York, New York 10010
    United States

    Site Not Available

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