The MIRIA Acne Scar Study (NCT05597267) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The MIRIA Acne Scar Study
United States75 participantsStarted 2022-11-04
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 …