METHODS

Subjects. The study enrolled women 21 to 75 years of age with Fitzpatrick skin types I to IV who were in generally good health, but complained of self-perceived thinning hair. Participating subjects expressed their willingness to maintain a consistent shampooing frequency and cut and color of their hair and agreed not to substantially change their current diet, medications, or exercise routines for the duration of the study. Women of childbearing potential were required to use a medically accepted form of birth control during the study.

Subjects were excluded from participation if they had a history of allergy or intolerance to fish, seafood, acerola, any shampoos or hair conditioners; were nursing, pregnant, or planning to become pregnant during the study; were participating in another clinical research study; had started the use of hormones for birth control or hormone replacement therapy within the prior six months; were currently undergoing a form of treatment for thinning hair including drug or light therapy within the last three months; or used prescription drugs known to affect the hair growth cycle within the last six months. Subjects with other hair loss disorders, such as alopecia areata, scarring alopecia, and androgenetic alopecia; self-reported uncontrolled diseases, such as diabetes, hypertension, hyperthyroidism, or hypothyroidism; self-reported active hepatitis, immune deficiency, human immunodeficiency virus, or autoimmune disease; or any known active dermatological condition, which, in the opinion of the investigator, might place the subject at a greater risk or interfere with clinical evaluations, were also excluded.

Procedures. During the baseline visit, inclusion/exclusion criteria were reviewed and each subject provided informed consent and signed a photography release form. A medical history was obtained from each subject, concomitant medications and lifestyle instructions were reviewed, and each subject underwent a physical examination and pregnancy testing. The scalp was examined to rule out the presence of any confounding scalp conditions. The investigator selected an approximately 4cm2 area of scalp along the frontalis bone at the junction of the frontal and lateral hairlines. This location was identified for further assessments using a three-point location noted on each patient according to measurements taken from medial canthus, lateral canthus, and preauricular skin pit to the hairline junction and digitally photographed (Nikkon SLR 200/300 camera with a Canfield EpiFlash). Following the baseline visit, subjects returned for evaluation after 90±7 and 180±7 days. At that time, the physical examination, vital signs, and digital photographs were repeated. In addition, subjects completed self-assessment questionnaires (Tables 1) and were queried about possible adverse events.

Test material. Subjects were randomized in double-blind fashion to receive the new oral supplement (Viviscal® Maximum Strength) or placebo. Viviscal contains AminoMar C™ marine complex, a proprietary blend of shark and mollusk powder, an organic form of silica derived from Equisetum sp. (horsetail), vitamin C derived from Malpighia emarginata (acerola cherry), microcrystalline cellulose (E460), natural orange flavor, magnesium stearate, hypromellose, and glycerol. Placebo treatment consisted of inert tablets with similar appearance. Subjects were instructed to take one tablet of their assigned treatment each morning and one tablet each evening with water following a meal.

Efficacy measures. The primary endpoint was the change in the number of terminal and vellus hairs in the target area of the scalp. The secondary endpoint was the change in patient self-assessment questionnaires following treatment (Tables 1).

Safety measures. Safety measures included spontaneous reports of adverse events and any adverse events disclosed during clinic evaluations and any changes noted during physical examinations.

Statistical analysis. The primary endpoint parameters measured during each evaluation were compared to baseline data using a paired t-test. Comparisons between active and placebo treatments were made using analysis of variance (ANOVA). Secondary endpoint parameters were compared using top box analysis. Differences were considered significant at the level of p≤0.05.

Ethics. This study protocol and informed consent agreement were reviewed and approved by an institutional review board. Written consent was obtained from all participants prior to their participation in any study-related activities. This study was conducted in accordance with applicable guidelines for the protection of human subjects for research as outlined in the United States Food and Drug Administration (FDA) 21 CFR Part 50, with the accepted standards for Good Clinical Practices and with the standard practices of the Ablon Skin Institute Research Center.