Viviscal Extra-Strength Formulation To Promote Hair Growth And Decrease Shedding In Women With Thinning Hair
Condition: Hair Thinning
MeSH terms: Alopecia; Alopecia Areata; Hypotrichosis
Study type: Interventional

Summary: 
      The Viviscal Extra-Strength formulation is an oral food/dietary supplement specifically
      designed to promote hair growth for women suffering from temporary thinning hair. It does not
      contain hormones or drugs and has been marketed in Europe for over 15 years. Viviscal
      Extra-Strength is marketed as Viviscal Maximum Strength in some other territories.

      The hypothesis of this clinical research study is that the ingestion of Viviscal
      Extra-Strength over a three (3) month period will strengthen and promote the growth of
      terminal hairs in female subjects, ages 21-65 years of age with self-perceived thinning hair
      associated with poor diet, stress, hormonal influences or abnormal menstrual cycles when
      compared to using the placebo tablet.
    

Detailed description: 
      The key ingredient of Viviscal Extra-Strength formulation is AminoMar C™ marine complex,
      Equisetum arvense sp. (horsetail), containing a naturally occurring form of silica),
      Malpighia glabra (acerola cherry) which contains Vitamin C, Biotin and Zinc. The AminoMar C™
      is an active ingredient which has been trademarked and comprises of a proprietary blend of
      shark powder and mollusc powder. It is derived from sustainable marine sources. Viviscal
      provides essential nutrients to nourish hair naturally from within. Viviscal works in many
      ways over several months of use to improve the appearance of thinning hair.

        -  Nourishes the hair follicles

        -  Strengthens and promotes the growth of terminal hairs. Terminal hair is defined as
           coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of
           40 micrometers. Vellus hair is defined as fine, short hairs found on the scalp with
           maximum cross-sectional diameter of 40 micrometers.

        -  Supports the growth of hair where it has slowed down or temporarily stopped

        -  Hair becomes stronger, healthier and more vibrant

      Ingestion of Viviscal Extra-Strength over a three (3) month period will strengthen and
      promote the growth of terminal hairs in female subjects, ages 21-65 years of age with
      self-perceived thinning hair associated with poor diet, stress, hormonal influences or
      abnormal menstrual cycles when compared to using the placebo tablet. The primary endpoints
      will be individual hair counts and favorable analysis using the Nikon CoolPix 4300 with 3GEN
      Dermlite Foto37 for phototrichogram analysis at the end of the three (3) month period. The
      secondary endpoints will be statistically significant decreased hair shedding counts with
      hair washing, favorable improvement in terminal hair diameter measured by the Dino-Lite
      Digital Microscopic and positive feedback on the Quality of Life and Self-Assessment
      questionnaires after three (3) months of Viviscal Extra-Strength ingestion.

      All patients enrolled must be identifiable throughout the study. The Investigator will
      maintain a personal list of patient numbers and patient names to enable records to be found
      at a later date and the list will be stored in a locked cabinet. Subject numbers consist of a
      2 digit number from 01 to 60. Patients will be randomized to active or placebo supplements
      (1:1 ratio) using a randomization table prepared prior to the start of the study by a
      non-participating staff member at the office of the Investigator. The study blind will not be
      broken until the end of the study. All test product and placebo will be labeled with subject
      numbers per the non-participating staff member. Subjects will be assigned a subject number in
      numerical order as enrolled. Randomization will occur by assignment to either Viviscal
      Extra-Strength supplement or placebo with 1:1 ratio. Subjects who terminate their study
      participation for any reason, regardless of whether study medication was used or not, will
      retain their randomization number.

      Visit Procedures Pre-Study Procedures

        1. Candidate subjects will be screened with the eligibility requirements by telephone prior
           to Visit 1.

        2. Candidate subjects will be assigned an appointment time for visiting the clinic.

      Visit 1: Baseline, Day 0

        1. Individuals will be given an informed consent (IC) document & photographic release form,
           HIPAA form, confidentiality agreement to read. They will have all of their study related
           questions answered by the Investigator or her designated staff and if they agree, they
           will sign two copies of the IC/Photography release form, two copies of the HIPAA form,
           and one copy of the confidentiality agreement. Subjects will be given one copy of the
           signed IC/Photography release and of the HIPAA agreement to keep, with one copy of each
           document remaining at the testing facility in the subject's file.

        2. Investigator and/or Study Coordinator will review with subject and complete the
           checklist for all inclusion and exclusion criteria.

        3. Investigator and/or Study Coordinator will review with subject and complete the
           checklist for medical history and concomitant medications.

        4. Investigator and/or Study Coordinator will review with subject and complete the General
           Lifestyle Questionnaire. The General Lifestyle Questionnaire may be found in Appendix V.

        5. Subjects will be given a Quality of Life Questionnaire to read and complete. The Quality
           of Life Questionnaire may be found in Appendix VI.

        6. Candidate subjects will receive a brief physical exam, including examination of the
           scalp, to rule out any immediately observable medical issues and any scalp
           alopecias/scalp disorders that are unacceptable for qualification. The physical will
           additionally include vital signs (pulse and blood pressure), weight and height.

        7. Candidate subjects of childbearing potential will complete a urine pregnancy test prior
           to product distribution.

        8. Candidate subjects who have completed all the initial paperwork and meet the
           inclusion/exclusion qualifications (to include findings of the physical exam) will be
           assigned a unique subject number. Subjects will be randomized to treatment group prior
           to dispensing the test product.

        9. Qualified subjects will have their scalp prepared for digital photography and initial
           measurements done (see Appendix I).

       10. Subjects will have the selected test site photographed (see Appendix I and II).

       11. Subjects will have ten (10) terminal hairs in the selected test site cut at the base of
           the scalp and the diameter of the hairs measured (see Appendix III).

       12. Subjects will be instructed to wash their hair at home 24 hours in advance of the study
           visit. Subjects will have their hair washed (shampooed) with Viviscal Gentle Shampoo
           over a sink containing cheesecloth (see Appendix IV). The cheesecloth will be positioned
           to collect shedding hair. The number of hairs collected in the cheesecloth will be
           counted and recorded. Subjects will be allowed to dry and style their hair.

       13. Subjects will be dispensed a three (3) month supply of the test product (three units of
           Viviscal Extra-Strength or Placebo, as randomized, containing 60 tablets each) and given
           written and verbal Usage and Lifestyle instructions (see Appendix VIII) and a calendar
           of future visit. Subjects will be instructed to ingest the test product per Sponsor
           instructions.

      Usage Instructions:

      Take two (2) tablets a day, one in the morning and one in the evening; take with water, after
      food.

      Subjects will be instructed to return all empty packets and unused test product at Visit 2.

      Lifestyle Instructions:

      Subjects will be instructed to maintain their normal hair care routine. Subjects will be
      instructed to use the same brand/type of hair care products and maintain the same haircut,
      color and style for the study duration.

      Subjects who have color treated hair will also be instructed to have the color treatment
      performed at the same time interval prior to each visit (ie. If on Visit 1, the color
      treatment was done one week prior then the color treatment is expected to occur at a similar
      interval of one week prior to Visit 2).

      Subjects will be instructed to come to each visit with clean (shampoo must be done 24 hours
      prior to the visit) and dry hair.

      Subjects will be instructed to use a medically sound form of birth control during the study.

      Visit 2: Month 3 (90 days) ± 1 week (7 days)

        1. A clinician will ask subjects if they have experienced any changes in their health or
           taken new/adjusted current medications since the last visit. If an AE or SAE is
           reported, the examining Investigator will be informed and the appropriate forms will be
           completed.

        2. The test product will be collected and counted for compliance.

        3. Subjects will receive a brief physical exam. The physical will include vital signs
           (pulse and blood pressure).

        4. Subjects will complete the Quality of Life Questionnaire and the Self-Assessment
           Questionnaire (see Appendix VI and VII).

        5. Subjects will have their scalp prepared for digital photography (see Appendix I).

        6. Subjects will have the selected test site photographed (see Appendix I and II).

        7. Subjects will have ten (10) terminal hairs in the selected test site cut at the base of
           the scalp and the diameter of the hairs measured (see Appendix III).

        8. Subjects will be instructed to wash their hair at home 24 hours in advance of the study
           visit. Subjects will have their hair washed (shampooed) with Viviscal Gentle Shampoo
           over a sink containing cheesecloth (see Appendix IV). The cheesecloth will be positioned
           to collect shedding hair. The number of hairs collected in the cheesecloth will be
           counted and recorded. Subjects will be allowed to dry and style their hair.

      All primary and secondary parameters will be collected at Visits 1 and 2. Missing data values
      will be minimized by intensive training of the interviewers in techniques of clarifying
      answers and checking questionnaires while participants are on-site. When missing values are
      identified, several approaches such as rescheduled within 24 hours of completion of tests or
      interviews will be employed to acquire the necessary data. Missing data will be also examined
      to assess randomness. Descriptive statistics will be obtained for all variables, tests of
      normality of continuous measures will be made and data will be examined for homogeneity of
      variance. An appropriate statistical method will be employed to correct for any
      abnormalities. All statistical tests will be two-tailed. Differences will be considered
      statistically significant provided a p-value of 0.05 or less is obtained but other p-values
      may be evaluated on a case-by-case basis. For each visit, the differences of the two groups
      from baseline Visit will be tested using analyses of variance with repeated measurements.
    

Intervention name(s): Viviscal Extra-Strength Supplement; Placebo tablet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The key ingredient of Viviscal Extra-Strength Supplement is AminoMar C™ marine complex, Equisetum arvense sp. (horsetail), containing a naturally occurring form of silica), Malpighia glabra (acerola cherry) which contains Vitamin C, Biotin and Zinc. The AminoMar C™ is an active ingredient which has been trademarked and comprises of a proprietary blend of shark powder and mollusc powder. It is derived from sustainable marine sources. Viviscal provides essential nutrients to nourish hair naturally from within. The Viviscal supplement is compared to the placebo tablet which contains no active ingredients. One tablet is taken by mouth in the morning and evening with food.; The placebo tablet contains no active ingredients. One tablet is taken by mouth in the morning and evening with food.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hair loss, hair thinning, women, marine protein supplement