Clinical Trial: To Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-site, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair

Brief 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 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. 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-Inv
    Sponsor: Irish Response t/a Lifes2good

    Current Primary Outcome:

    • Hair shedding rate [ Time Frame: 6 months ]
      The numbers of scalp hairs shed at month 3 and month 6 when compared with baseline values.
    • Hair fiber diameter [ Time Frame: 6 months ]
      Mean vellus hair width change


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Quality of life questionnaires [ Time Frame: 6 months ]

    Quality of life questionnaires relating to perception of quality of hair growth and their wellbeing.


    Original Secondary Outcome: Same as current

    Information By: Irish Response t/a Lifes2good

    Dates:
    Date Received: November 7, 2014
    Date Started: April 2011
    Date Completion:
    Last Updated: November 13, 2014
    Last Verified: November 2014