Phase
Condition
Acne
Scalp Disorders
Rash
Treatment
AVAVA
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects between 18 to 70 years of age.
Dermatologic condition that can be addressed by the laser, including but not limitedto:
Wrinkles
Scars
Acne Scars
Active Acne
Dyschromia
Cutaneous Lesions such as Age or Sun Spots
Melasma
Laxity
Willingness to have digital photographs taken of treatment area(s) and agreementwith use of photographs for presentation, educational, or marketing purposes.
Willingness to comply with the following during the study, including the follow-upperiod:
maintain consistent skin care regimen on treated areas.
cover treated areas or have very limited sun exposure and, if requested, use anapproved sunscreen of SPF 50 or higher.
refrain from using systemic corticosteroids, according to Investigatordiscretion.
refrain from using topical corticosteroids, retinoids, or prescriptionskin-lightening medications on the treated areas, according to Investigatordiscretion.
refrain from any other procedures in the treatment areas.
Willingness and ability to comply with study instructions and return for requiredvisits.
Subject has read and signed a written informed consent form.
Subject lives within 50 miles of study site.
Willingness to shave hair in intended treatment area
Exclusion
Exclusion Criteria:
Skin pathology or condition that could interfere with evaluation of the studyprocedure, e.g.,
Systemic treatment prescribed within previous 6 months (e.g., oral medication suchas isotretinoin)
Surgical treatment in the target areas within previous 6 months (e.g., lasersurgery)
Active vitiligo, psoriasis, or eczema in the treatment area
Injection of dermal filler in the target areas within previous 1 month (e.g.,collagen, hyaluronic acid filler)
Cosmetic procedures in the target areas within prior 3 months (e.g., laser,microdermabrasion, skin peel)
Topical treatment applied to target areas within the previous 1 month or accordingto Investigator discretion.
Active suntan and unable or unlikely to refrain from tanning within the follow-upperiod.
Artificial tanning in the target areas within the previous 1 month (e.g., spray,lotion, tanning bed) or intention to use artificial tanning within the follow-upperiod.
Active localized or systemic infection, or an open wound in area being treated.
Lesions in the treatment areas suspicious for malignancy (skin cancer, melanoma)
History of abnormal wound healing or abnormal scarring (e.g., hypertrophic orkeloid)
History of connective tissue disease, such as lupus or scleroderma.
Any use of medication that is known to increase sensitivity to light according toInvestigator's discretion (e.g., topicals that produce sensitivity to light may beused in areas other than the target area).
History of gold therapy.
History of disease stimulated by heat, such as recurrent herpes simplex or herpeszoster (shingles) in the treatment area, unless treatment is conducted following aprophylactic regimen.
History of radiation to the treatment area or currently undergoing systemicchemotherapy for the treatment of cancer.
For Female: Pregnancy or lactation, or intent to become pregnant within the studyperiod.
Significant uncontrolled concurrent illness, such as diabetes mellitus orcardiovascular disease, e.g., uncontrolled hypertension.
History of immunosuppression/immune deficiency disorder or currently usingimmunosuppressive medications.
Current enrollment in a clinical study of any other unapproved investigational drugor device
Any other condition or laboratory value that would, in the professional opinion ofthe investigator, potentially affect response or participation in this clinicalstudy, or would pose an unacceptable risk to the subject.
Study Design
Connect with a study center
AVAVA, Inc.
Waltham, Massachusetts 02451
United StatesActive - Recruiting
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