Phase
Condition
Inflammatory Comedones
Scar Tissue
Acne
Treatment
MIRIA Laser
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Enchantress Dermatology
Miami, Florida 33173
United StatesSite Not Available
AVAVA, Inc.
Waltham, Massachusetts 02451
United StatesSite Not Available
Laser and Skin Surgery Center of New York
New York, New York 10010
United StatesSite Not Available
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