Efficacy of the New Viviscal Professional Strength Oral Supplement in Females With Thinning Hair
Condition: Hair Thinning
MeSH terms: Alopecia; Alopecia Areata; Hypotrichosis
Study type: Interventional

Summary: 
      The New Viviscal Professional Strength is an oral food supplement specifically designed to
      promote hair 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 purpose of this clinical research study is to evaluate certain physiological effects of
      Viviscal compared to placebo in forty (40) female subjects, ages 21-75 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 is AminoMar C™ marine complex, 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. 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 4 stages (see below) over several months of use to improve the
      appearance of thinning hair.

      STAGE 1: Nourishes the hair follicles STAGE 2: 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.

      STAGE 3: Supports the growth of hair where it has slowed down or temporarily stopped STAGE 4:
      Hair becomes stronger, healthier and more vibrant

      Ingestion of Viviscal over a six (6) month period will strengthen and promote the growth of
      terminal hairs in female subjects, ages 21-75 years of age with self-perceived thinning hair
      associated with poor diet, stress, hormonal influences or abnormal menstrual cycles. The
      primary endpoints will be individual hair counts and favorable analysis using the Nikon
      CoolPix 4300 with 3GEN Dermlite Foto37 or Nikon D90 camera with a Nikor 105 mm macro lens for
      phototrichogram analysis at the end of the six (6) month period. The secondary endpoints will
      be favorable improvements in terminal hair diameter measured by the Dino-Lite Digital
      Microscopic and positive feedback on the Quality of Life and Self-Assessment questionnaires
      after six (6) months of Viviscal 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 40. 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 Investigators. 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 New
      Viviscal professional 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.

      Subjects will be assigned a two-digit number which will uniquely identify every subject on
      the study. This number will remain with the subject throughout the study and should be used
      in all references to the individual in this study. No number will be reassigned once the
      study begins. Subjects at the ASIRC will start with 01 to 20 and at DeNova Research 21 to 40.
      Patients will be identified solely by this number and any paper records which reflect
      electronic data or relationships of those data with patient confidential information are kept
      in locked cabinets.

      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 his/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
           IV.

        5. Subjects will be given a Quality of Life Questionnaire to read and complete. The Quality
           of Life Questionnaire may be found in Appendix V.

        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 dispensed a three (3) month supply of the test product (three units of
           Viviscal or Placebo, as randomized, containing 60 tablets each) and given written and
           verbal Usage and Lifestyle instructions (see Appendix VII) and a calendar of future
           visits. 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 Visits 2
      and 3.

      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 Visits 2 and 3).

      Subjects will be instructed to come to each visit with clean (shampoo in the morning on the
      day of 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. Subjects found to be
           consistently out of compliance will be reminded of the correct usage instructions.

        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 V and VI).

        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 dispensed a three (3) month supply of the test product, (three units of
           Viviscal or Placebo, as randomized, containing 60 tablets each), and given written and
           verbal Usage and Lifestyle instructions (See Appendix VII). Subjects will be instructed
           to ingest the test product per Sponsor instructions.

      Visit 3: Month 6 (180 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.

        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 V and VI).

        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).

      All primary and secondary parameters will be collected at Visits 1, 2 and 3. 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. 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): New Viviscal Professional Supplement; Placebo tablets
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The key ingredient is AminoMar C™ marine complex, 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. 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 thinning, hair loss, alopecia, women, oral supplement