A Randomized, Double -Blind,, Sham-Device-Controlled, Multicenter, 24-Week Clinical Trial to Evaluate the Safety and Effectiveness of the iRestore ™ Hair Rejuvenation System in the Treatment of Male and Female Androgeneticalopecia

Fecha de inicio: 1 de julio de 2012

Inclusion Criteria: Individuals eligible for inclusion in the study are those who: Are male or female, 25 to 60 years of age; If male, have Norwood-Hamilton classifications of IIa to V male pattern baldness; If female, have Ludwig Scale classifications I-4, II-1, II-2, or frontal; Are willing to have a tattoo created on the target area; Have been experiencing active hair loss within the last 12 months; In the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence or partner's vasectomy: abstinence or partner's vasectomy are acceptable if the female agrees to implement one of the other acceptable methods of birth control if her lifestyle or partner changes); Have Fitzpatrick Skin Type I-IV (See Table 1 Below); Are willing to have the target area hair clipped; Read, understand, and sign a photographic release form(s); and Read, understand, and sign an informed consent document after being advised of the nature of the study. Table 1: Fitzpatrick Skin Types I Always burns easily, never tans II Always burns easily, tans minimally III Burns moderately, tans gradually (light brown) IV Burns minimally, always tans well (moderate brown) V Rarely burns, tans very well (moderate brown) VI Never burn, deeply pigmented Exclusion Criteria: Individuals excluded from participation in the study are those who: Have used any of the following medications within 6 months prior to enrollment: minoxidil, finasteride (or any other 5α-reductase inhibitor medications); medications with anti-androgenic properties (eg, cyproterone, spironolactone, ketoconazole, flutamide, and bicalutamide); topical estrogens, progesterone, tamoxifen, anabolic steroids; medications that can potentially cause hypertrichosis (eg, ciclosporin, diazoxide, phenytoin, and psoralens); oral glucocorticoids (inhaled glucocorticoids are permitted); lithium or phenothiazines; medications of known or suspected phototoxicity (eg, tetracyclines, thiazides, certain NSAIDs); other medications which, in the opinion of the investigator, may interfere with the performance of study assessments or place the subject at undue risk; Will not agree to refrain from changing hair color and hair style during the course of the study; Have had a hair transplant, scalp reduction, hair weave, or tattoo which, in the opinion of the investigator, may interfere with the performance of the study assessments; Are using or have used depilatories, razors, or wax on the scalp to an extent which, in the opinion of the investigator, may interfere with the performance of the study assessments; Have psoriasis, active dermatitis/eczema, or severe acne on the scalp area; Have diabetes requiring exogenous insulin; Have cataracts; Have any medical condition which, in the opinion of the investigator, could affect hair growth (eg, Human Immunodeficiency Virus, connective tissue disease, inflammatory bowel disease); Have very little contrast between hair color and scalp, eg, are of a fair hair color (eg, white or very blond) and have very pale skin; Are females who are pregnant, planning to become pregnant during the study, or breastfeeding; and/or Are, in the opinion of the investigative personnel, unable to comprehend and/or otherwise comply with any aspect of study requirements.