| Eligibility |
Inclusion Criteria:
- Female or Male, 16 to 50 years of age (inclusive).
- Fitzpatrick Skin Type I-VI
- Has clinically diagnosed acne vulgaris of moderate to severe on each hemiface and
inflammatory acne lesions as determined by the blinded trained investigator (or
qualified designee) using the Investigator's Global Assessment Scale.
- Subject (and legally authorized representative/substitute decision maker if subject is
incapable of providing informed consent) must be able to read, speak, and understand
English and sign the Informed Consent Form.
- Willing to stop using topical acne medications on the face for 2 weeks prior to
baseline and systemic acne medications for 1 month prior to baseline and for the
duration of the study.
- Willing and able to adhere to the treatment and follow-up schedule and
pre/post-treatment care instructions.
- Willing to have very limited sun exposure (including avoiding tanning booths, sun
lamps, sunbathing) and use an approved sunblock or sunscreen of SPF (Skin Protection
Factor) 30 or higher on the face every day for the duration of the study, including
the follow-up period.
- Willing to have photographs taken of the face and agree to the use of photographs for
presentation, educational or marketing purposes.
- Agree to not undergo any other procedure(s) or add any new treatment modalities in the
target area during the study.
Exclusion Criteria:
- Has clinically diagnosed acne vulgaris of severity grade of clear, almost clear, or
mild on at least one hemiface as determined by the blinded trained investigator (or
qualified designee) using the Investigator's Global Assessment Scale.
- Prior treatment to the target area during participation in a clinical trial of another
device or drug within 1 month (30 days) prior to study participation.
- Prior treatment to the target area within 1 month of study participation including
chemical peel, dermabrasion/microdermabrasion, microneedling, radiofrequency
treatment, laser or light-based procedures, cryodestruction or chemodestruction,
intralesional steroids, photodynamic therapy, or acne surgery.
- Prior injection of botulinum toxin in the target area within 1 month of study
participation and for the duration of the study.
- Prior injection of collagen, hyaluronic acid filler or other dermal/tissue filler in
the target area within 2 weeks of study participation.
- Systemic use of retinoid, such as isotretinoin, within 6 months of study
participation.
- Started or changed hormonal contraception within 6 months of study participation or
intends to start or change hormonal contraception through duration of the study. If
subject has not changed hormonal contraception within 6 months of study participation
and has intent of continuation through duration of this study, ok to enroll.
- History of malignant tumors in the target area.
- Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) or facial adornments
(studs, piercings, tattoos) that may preclude treatments, photos or accurate lesion
assessments in the target area.
- Pregnant and/or breastfeeding or planning to become pregnant during the study.
- Presence of any skin condition in the target area (e.g., eczema, psoriasis,
dermatitis, rash, papulo-pustular rosacea, infection) that would interfere with the
diagnosis or assessment of acne vulgaris.
- Any medical condition that, in the opinion of the Investigator, would interfere with
patient's participation in the full study protocol (e.g., severe Diabetes Mellitus or
Cardiovascular Disease).
- Suffering from diagnosed coagulation disorders or taking prescription anticoagulation
medications.
- History of diagnosed immunosuppression/immune deficiency disorders or currently using
immunosuppressive medications.
- History of diagnosed connective tissue disease, such as systemic lupus erythematosus
or scleroderma.
- Known hypersensitivity to, history of allergic reaction to, or contraindication to
Pro-Nox (or similar) if administered.
- Any use of medication that is known to increase sensitivity to light according to
Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes
zoster (shingles) in the target area, unless treatment is conducted following a
prophylactic regimen.
- History of radiation to the target area, currently undergoing treatment for skin
cancer in the target area or undergoing systemic chemotherapy for the treatment of
cancer.
- History of diagnosed pigmentary disorders (including vitiligo) in the target area.
- Facial tan or unable/unlikely to refrain from tanning on the face during the study.
- As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study.
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