| Eligibility |
Inclusion Criteria:
1. Men and women 50 to 75 years of age having general good health.
2. Individuals deemed by the Investigator, visually, to have signs of hand aging
(presence of skin laxity, age spots, trophic changes) on the dorsum of the hand..
Also, Subjects would have to be willing to undergo correction of these signs of aging.
3. Individuals willing to withhold aesthetic therapies to the areas of the hand 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, laser treatments, and tightening
treatments, etc.) for the duration of the study. Waxing and threading is allowed but
not laser hair removal.
4. Individuals that are willing to provide written informed consent
5. Individuals willing to sign a photography release.
6. 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.
7. Women of child bearing potential agree to take a urine pregnancy test at the Baseline
visit and 3-months post-treatment or when deemed by Investigator and/or Sponsor. This
may be changed to a monthly pregnancy test at the Sponsor's discretion. 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.
Exclusion Criteria:
1. Individuals diagnosed with known allergies to general skin care products.
2. Individuals who have presence of an active systemic or local skin disease 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 areas to be treated
(< 6 months).
7. Individuals who have significant scarring in the area(s) to be treated.
8. Individuals who have a recent or current history of inflammatory skin disease,
infection or unhealed wound.
9. 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 one 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 five 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 three months;
- Ablative resurfacing laser treatment;
- Non-ablative, rejuvenative laser or light treatment within the past six months;
- Surgical dermabrasion;
- Had a chemical peel or dermabrasion, of the dorsum of the hand within four weeks
19. Individuals with a history of using the following prescription medications:
- Accutane or other systemic retinoids within the past six months;
- Topical Retinoids within the past two 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 four 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 two 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.
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 on the 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 have observable suntan, nevi, excessive hair, etc. or other dermal
conditions on the back of the hand that might influence the test results in the
opinion of the Investigator or designee.
26. 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 cosmetic treatments to the treatment area; 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).
27. Individuals who started hormone replacement therapies (HRT) or hormones for birth
control less than three months prior to study entry or who plan on starting, stopping,
or changing doses of HRT or hormones for birth control during the study.
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