To Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair
Condition: Hair Thinning
MeSH terms: Alopecia; Alopecia Areata; Hypotrichosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Viviscal Oral Supplement Tablets
Intervention type(s): Dietary Supplement
Intervention description(s): Tablet (512 mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Hair thinning