| Eligibility |
Inclusion Criteria:
1. Adult males and females, ages 18 through 45, at the time the ICF is signed.
2. Clinical diagnosis of Acne Vulgaris
3. Investigator's Global Assessment (IGA) Score 1,2 or 3
4. Individuals willing to withhold aesthetic therapies to the areas of the face being
treated or judged to potentially impact results by the Investigator (e.g. soft tissue
fillers and/or any resurfacing procedures, botulinum toxin, injectable fillers,
microdermabrasion, IPL (intense pulsed light), peels, facials, laser treatments, and
tightening treatments, etc.) for the duration of the study. Waxing and threading is
allowed but not facial laser hair removal.
5. Women of childbearing potential agree to take a urine pregnancy test at the Baseline
visit. Women who are of childbearing potential must have a negative urine pregnancy
test result and must not be lactating at the baseline visit. Women must be willing and
able to use an acceptable method of birth control (e.g. barrier methods used with a
spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during
the study. Women will not be considered of childbearing potential if one of the
following conditions is documented on the medical history:
- Postmenopausal for at least 12 months prior to study;
- Without a uterus and/or both ovaries;
- Bilateral tubal ligation at least 6 months prior to study enrollment.
6. Individuals of childbearing potential who use an acceptable method of contraception
throughout the study. Acceptable methods of birth control include:
1. Established use of hormonal methods of contraception (oral, injected, implanted,
patch or vaginal ring) at least 3 months prior to study enrollment;
2. Barrier methods of contraception with spermicide: condom or occlusive cap
(diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository.
3. Intrauterine device (IUD) or intrauterine system (IUS)
4. Surgical sterilization (e.g., vasectomy that has been confirmed effective by
sperm count check, tubal occlusion, hysterectomy, bilateral
salpingectomy/oophorectomy)
5. Abstinence from heterosexual intercourse, when this is in line with the preferred
and usual lifestyle of the subject. Periodic abstinence (e.g., calendar,
ovulation, symptothermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception.
7. Individuals that are willing to provide written informed consent and are able to read,
speak, write and understand the informed consent document.
8. Willingness to cooperate and participate by following study requirements for the
duration of the study and to report any changes in health status or medications,
adverse event symptoms, or reactions immediately.
Exclusion Criteria:
1. Individuals diagnosed with known allergies to facial or general skin care products.
2. Individuals who have presence of an active systemic or local skin disease, other than
Acne Vulgaris, that may affect wound healing.
3. Individuals who have severe solar elastosis.
4. Individuals with sensitivity to topical lidocaine.
5. Individuals who have physical or psychological conditions unacceptable to the
Investigator.
6. Individuals who have a recent history of significant trauma to the face (< 6 months).
7. Individuals who have significant scarring, other than atrophic acne scars, in the
area(s) to be treated.
8. IGA Score 0 or 4.
9. Individuals who have a recent or current history of inflammatory skin disease other
than Acne Vulgaris, infection, cancerous/pre-cancerous lesion, unhealed wound in the
proposed treatment areas. Individuals who have a history of systemic granulomatous
diseases, active or inactive, (e.g. Sarcoid, Wegeners, TB, etc.) or connective tissue
diseases (e.g. lupus, dermatomyositis, etc.).
10. Individuals who currently have or have a history of hypertrophic scars, or keloid
scars.
11. Individuals who currently have cancerous or pre-cancerous lesions in the areas to be
treated and/or with a history of skin cancer.
12. Individuals who have the inability to understand instructions or to give informed
consent.
13. Individuals who have had microdermabrasion or glycolic acid treatment to the treatment
area(s) within 1 month prior to study participation or who will have this treatment
during the study.
14. Individuals who have a history of chronic drug or alcohol abuse.
15. Individuals undergoing concurrent therapy that, in the Investigator's opinion, would
interfere with the evaluation of the safety or efficacy of the study device.
16. Individuals who, in the Investigator's opinion, have a history of poor cooperation,
noncompliance with medical treatment, or unreliability.
17. Individuals who are current smokers or have smoked in the last 5 years.
18. Individuals who have a history of the following cosmetic treatments in the area(s) to
be treated:
- Skin tightening procedure within the past year;
- Injectable filler of any type within the past:
- 12 months for Hyaluronic acid fillers (e.g. Restylane)
- 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)
- 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra)
- Ever for permanent fillers (e.g. Silicone, ArteFill)
- Neurotoxins within the past 3 months;
- Ablative resurfacing laser treatment within the past year;
- Non-ablative, rejuvenative laser or light treatment within the past 6 months;
- Surgical dermabrasion or deep facial peels within the past 6 months;
- Had a chemical peel, dermabrasion, non-ablative laser or fractional laser
resurfacing of the face and neck within 6 months
19. Individuals with a history of using the following prescription and over-the-counter
medications:
- Accutane or other systemic retinoids within the past 6 months;
- Topical Retinoids or Steroids within the past 2 weeks;
- Prescription strength skin lightening devices (e.g. hydroquinone, tretinoin, AHA,
BHA and polyhydroxy acids, 4-hydroxyanisole alone or in combination with
tretinoin, etc.) within 4 months;
- Any anti-wrinkle, skin lightening devices, or any other device or topical or
systemic medication known to affect skin aging or dyshcromia (devices containing
alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or
licorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract
(topically), emblica extract, etc.) within 2 weeks;
- Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID
use); and/or
- Psychiatric drugs that in the Investigator's opinion would impair the subject
from understanding the protocol requirements or understanding and signing the
informed consent.
- Topical Acne treatments including over-the-counter preparations
- Topical anti-inflammatory agents, or
- Topical antibiotics
20. Individuals who are nursing, pregnant, or planning to become pregnant during the study
according to subject self-report.
21. Individuals having a health condition and/or pre-existing or dormant dermatologic
disease, other than Acne Vulgaris, on the face or body (e.g., psoriasis, rosacea,
eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions
such as post inflammatory hyperpigmentation) that the Investigator or designee deems
inappropriate for participation or could interfere with the outcome of the study.
22. Individuals with a history of immunosuppression/immune deficiency disorders (including
HIV infection or AIDS) or currently using immunosuppressive medications (e.g.,
azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate
mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined
by study documentation.
23. Individuals with an uncontrolled disease such as asthma, diabetes, hyperthyroidism,
medically significant hypertension or hypothyroidism. Individuals having multiple
health conditions may be excluded from participation even if the conditions are
controlled by diet, medication, etc.
24. Individuals with any planned surgeries, overnight hospitalization, and/or invasive
medical procedures during the course of the study.
25. Individuals who are currently participating in any other study involving the use of
investigational device or drugs at another research facility or doctor's office within
4 weeks prior to inclusion into the study.
26. Individuals who have observable suntan, nevi, excessive hair, etc. or other dermal
conditions on the face that might influence the test results in the opinion of the
Investigator or designee.
27. Individuals who have any condition, which in the opinion of the Investigator makes the
patient unable to complete the study per protocol (e.g. patients not likely to avoid
other facial cosmetic treatments; patients not likely to stay in the study for its
duration because of other commitments, concomitant conditions, or past history;
patients anticipated to be unreliable, or patients who have a concomitant condition
that may develop symptoms that might confuse or confound study treatments or
assessments).
28. Individuals who started hormone replacement therapies (HRT) or hormones for birth
control less than 3 months prior to study entry or who plan on starting, stopping, or
changing doses of HRT or hormones for birth control during the study.
29. Subjects who have received radiation therapy and/or anti-neoplastic agents within 90
days prior to baseline
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