To Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair
To Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair
The purpose of this multi-site, double-blind, placebo-controlled clinical study, conducted
 for Lifes2Good, is to evaluate certain physiological effects of Viviscal Oral Supplement
 compared to a placebo in female subjects with self-perceived thinning hair associated with
 poor diet, stress, hormonal influences, or abnormal menstrual cycles.

 Viviscal is an oral food supplement specifically designed to promote the quality of existing
 hair growth and/or to promote new hair re-growth for women suffering from temporary thinning
 hair. It does not contain hormones, drugs, or industry by-products. Viviscal has been
 marketed in Europe for over 15 years. The key ingredient is AminoMar C - a protein rich
 compound of marine extracts blended with soluble silica and fortified with Vitamin C.
 Viviscal provides essential nutrients to nourish hair naturally from within. Viviscal works
 over several months of use to improve the appearance of thinning hair.
The purpose of this multi-site, double-blind, placebo-controlled clinical study, conducted
 for Lifes2Good, is to evaluate certain physiological effects of Viviscal Oral Supplement
 compared to a placebo in female subjects with self-perceived thinning hair associated with
 poor diet, stress, hormonal influences, or abnormal menstrual cycles. A total of 72 female
 subjects (36 subjects at the Dallas Research Center and 36 subjects at the Colorado Research
 Center) completed the study.

 At day 0, prior to clinical procedures, subjects were assigned to 1 of the 2 treatment
 groups, Viviscal Oral Supplement or Placebo Tablets, based on the completely randomized study
 design that was generated with no input of subject information and conditions. During the
 course of the study, subjects consumed 1 tablet (512 mg) 3 times per day of the assigned test
 material, Viviscal Oral Supplement or Placebo Tablets, with water after food.

 Clinical evaluations were conducted at visit 1 (day 0), visit 2 (day 2), visit 3 (3 months ±
 2 weeks), visit 4 (2 days after visit 3), visit 5 (6 months ± 2 weeks), and visit 6 (2 days
 after visit 5). Subjects participated in the following procedures at the indicated time
 points:

 -  Scalp Examination At day 0, each subject's scalp was examined by the Sub-Investigator to
 rule out any confounding scalp conditions.

 -  Physical Examination A qualified nurse/nurse practitioner performed a basic physical
 examination of each subject at day 0, 3 months±2 weeks, and 6 months±2 weeks. The
 physical examination included a basic body systems overview, vital signs (blood pressure
 and pulse), respiration rate, temperature, weight, and height. Additionally, at the
 Colorado Research Center, the Sub-Investigator and qualified nurse practitioner examined
 each subject's scalp.

 -  Test Site Selection and Preparation At day 0, the examining Sub-Investigator selected a
 target area on each subject's scalp. To prepare the target areas for digital
 photography, subjects underwent shaving of the target areas at day 0, 3 months±2 weeks,
 and 6 months±2 weeks. Hair dyeing of the target areas was performed at day 0 and (if
 fading had occurred) at day 2, 3 months±2 weeks, 2 days after visit 3, 6 months±2 weeks,
 and 2 days after visit 5. Subjects underwent demarcation of the target areas with a
 small black dot tattoo at day 0 and (if fading had occurred) at 3 months±2 weeks and 6
 months±2 weeks. For post-day 0 time points, tattooing procedures (if needed) were
 performed after the photography procedures.

 -  Digital Photography Macro photographs were captured of each subject's target area
 selected by the Sub-Investigator at all study visits.

 -  Shed Hair Collection Procedures At day 2, 2 days after visit 3, 2 days after visit 5, a
 clinician shampooed each subject's hair in a normal washing manner over a sink with
 securely fastened cheesecloth positioned to catch any hairs that were shed from the
 scalp. A clinician gently combed through the hair and rinsed any shed hairs from the
 comb onto the cheesecloth. Shed hairs found in the cheesecloth were counted and
 recorded.

 -  Questionnaire Each subject completed a quality of life questionnaire at baseline (day
 0), 2 days after visit 3 and 2 days after visit 5 and a consumer questionnaire at 2 days
 after visit 3 and 2 days after visit 5.

 -  Daily Diary During the course of the study, subjects completed a daily diary to record
 product application times, any comments, and responses to a weekly question regarding
 their hair loss.

 -  Interviews At day 0, a portion of the subjects (at the Dallas Research Center) was
 selected to be interviewed and filmed. Film interviews were conducted for the
 pre-selected subjects at day 2 and 2 days after visit 5.
Inclusion Criteria:

 1. Females, ages 21-55 years of age.

 2. Clinically-determined general good health as determined by responses to the initial
 paperwork.

 3. Females with self-perceived thinning hair associated with poor diet, stress, hormone
 influences or abnormal menstrual cycle.

 4. Females willing to maintain their normal hair shampooing frequency.

 5. Females willing to add the provided oral supplement to their current daily routine.

 6. Females willing to not substantially change their current diet, medications, or
 exercise routines for the duration of the study. If a subject receives physician
 guidance during the study to change diet, medications, or exercise routine, the
 subject will need to notify the clinic as soon as possible.

 7. Females willing to undergo a brief physical exam to include height, weight, blood
 pressure, pulse, general physical findings and a scalp exam. The physical exam will
 occur at Visits 1, 3, and 5.

 8. Females willing to have a small dot tattoo applied to the scalp, a small area of hair
 shaved (approximately 1 cm2) to approximately 1 mm in length, remaining hair in that
 small area dyed black, and to have photographs performed. If the dot tattoo fades
 substantially by Visit 3, it may need to be re-inked.

 9. Females willing to wash their hair at the testing facility at Visits 2, 4 and 6 with
 the provided normal shampoo. Subjects may bring their own conditioner to use after
 shampooing.

 10. Individuals with Fitzpatrick I-III photo skin types, (Fitzpatrick IV may be enrolled
 at the discretion of the clinical investigator).

 11. Willingness to maintain a consistent haircut and hair color throughout the 6 month
 study period.

 Exclusion Criteria:

 1. Females with a known history of intolerance or allergy to fish, seafood or acerola.

 2. Individuals with any known allergy or sensitivity to any shampoo/conditioner.

 3. Females who are nursing, pregnant, planning to become pregnant during the study.

 4. Females who are participating on any clinical research study at Stephens or at another
 research center or doctor's office.

 5. Females who have recently (within the last 6 months) started the use of hormones for
 birth control or hormone replacement therapy (HRT). Women currently using hormones for
 birth control or HRT must have been on a stable dose (6 months or longer) in order to
 be eligible for the study.

 6. Females currently using the HairMax light treatment to treat thinning hair.

 7. Females who have regularly used Rogaine (Minoxidil) or Nizoral/Ketoconazole within the
 last 3 months.

 8. Females who have used prescription drugs known to affect the hair growth cycle within,
 6 months (e.g., hormone-based birth control for less than 6 months).

 9. Females suffering from other hair loss disorders, such as alopecia areata, scarring
 alopecia or androgenetic alopecia.

 10. Females who have had hair transplants within 6 months of study start.

 11. Individuals with self-reported uncontrolled diseases (i.e. diabetes, hypertension,
 hyperthyroidism, hypothyroidism, etc. Medical conditions that are under control with
 or without treatment will be considered on an individual basis by the Investigators.

 12. Females with self-reported active hepatitis, immune deficiency, HIV or autoimmune
 disease.

 13. Females having a known active dermatologic condition which, in the opinion of the
 examining Investigator, might place the subject at a greater risk or interfere with
 clinical evaluations (e.g., seborrheic dermatitis, psoriasis, atopic dermatitis,
 advanced skin cancer, etc.)