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Recruiting
NCT05597267
The MIRIA Acne Scar Study
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 75
Sponsor: AVAVA, Inc.
Location: United States
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 Criteria:Subjects 18-65 years of ageAcne scars on the faceAble 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 regionOn medication known to increase sensitivity to sunlightSeizure disorder triggered by lightTakes or has taken oral isotretinoin, such as Accutane®, within the last six monthsUse of topical over the counter or prescription retinoids such as Retinol creams, gels, Tazarotene, Tretinoin, Adapalene, within the last 30 daysActive acne or rosaceaActive localized or systemic infection, or an open wound or abscess in area being treatedSignificant systemic inflammatory disease or illness, such as lupus, or an illness localized in area being treatedCommon acquired nevi that are predisposed to the development of malignant melanomaCurrent or prior herpes simplex in the target treatment areaIs receiving or has received gold therapyCurrently 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 entryFacial 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 monthsInjection 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 therapySignificant uncontrolled concurrent illness, such as diabetes mellitus, hypertension, or cardiovascular diseaseHistory of immunosuppression/immune deficiency disorder or currently using immunosuppressive medicationsPlanned weight loss of greater than five poundsFacial hair in the treatment areas which would prevent evaluation of the outcome measures.
For men, must be clean shaven in the area of treatmentAny 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 participationIs 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 supplementsTaking medications that alter the wound-healing response or evidence of compromised wound healingKnown history of keloid formationKnown history of medical diseases that may cause koebnerization (the appearance of disease in another location), such as vitiligo, psoriasis or lichen planusHistory of skin cancer or suspicious lesions in treatment areaSubject 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.
Source: ClinicalTrials.gov (NCT05597267). StuddyBuddy aggregates publicly available trial information.