| Eligibility |
Inclusion Criteria:
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - III.
- Subject has black or dark brown unwanted arm hair of fine texture.
- Willing to have the hair removal procedure on one forearm only, and within the
designated study treatment area.
- Willing and able to adhere to the treatment and follow-up schedule, and the study
"Before and After Procedure Instructions".
- Willing to refrain from shaving the treatment area for 5 days prior to each study
visit.
- Must be able to read, understand and sign the Informed Consent Form.
- Must agree not to use hair removal products, such as topical chemical depilatories, or
undergo any other hair removal procedure during the study, such as other laser and
light therapies or waxing.
- Willing to refrain from excess sun exposure and willing to wear sunscreen on the
treatment area during the study (including the follow-up period).
- Willing to have digital photographs taken of the treatment area and agree to use of
photographs for presentation, educational or marketing purposes.
- Must be in good health, as determined by the Investigator.
- Must be post-menopausal or surgically sterilized, or using a medically acceptable form
of birth control at least 3 months prior to enrollment and during the entire course of
the study.
Exclusion Criteria:
- Participation in a clinical trial of another device or drug within 6 months prior to
enrollment, or during the study.
- Had any type of professional hair removal procedure, such as laser, light-based, RF or
electrolysis, in the treatment area within 12 months of study participation.
- Had other epilation treatment, such as waxing or mechanical epilator, in the treatment
area within 6 months of study participation.
- Subject shows signs of actinic bronzing or recent tanning in the treatment area, and
unable/unlikely to refrain from tanning during the study.
- Subject is pregnant and/or breastfeeding.
- Suffering from significant concurrent illness, such as diabetes mellitus or pertinent
neurological disorders.
- Having malignant or pre-malignant lesions in the treatment area, or history of a
malignant skin disease.
- Current acute or chronic skin infections or inflammatory processes, affecting the
treatment area, such as dermatitis.
- Currently using immunosuppressive medications or history of immunosuppression/immune
deficiency disorder, such as psoriasis, eczema, vitiligo, systemic lupus erythematosus
or scleroderma.
- Current use of any medication that is known to increase sensitivity to light, such as
tetracycline.
- Currently undergoing systemic chemotherapy or radiation treatment for cancer, or
history of treatment within 3 months of study participation.
- Suffering from coagulation disorders or taking prescription anticoagulation
medications.
- History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
- History of seizure disorders due to light.
- History of diseases stimulated by heat, such as recurrent herpes zoster in the
treatment area, unless treatment is conducted following a prophylactic regimen.
- History of pigmentary disorders, particularly tendency for hyper- or
hypo-pigmentation.
- History of tattoo, permanent make-up or semi-permanent or permanent tissue fillers in
the treatment area.
- Systemic use of a retinoid (such as Accutane) or corticosteroid within 6 months of
study participation.
- Current smoker or history of smoking within 12 months of study participation.
- Anytime in life, had used gold therapy (gold salts) for disorders such as
rheumatologic disease or lupus.
- As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study.
|
