Clinical Trial: Viviscal Extra-Strength Formulation To Promote Hair Growth And Decrease Shedding In Women With Thinning Hair

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

Official Title: A 3-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Ability Of Viviscal Extra-Strength Formulation To Promote Hair Growth And Decrease Shedding In Women With Self-Perceived Th

Brief 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 Summary:

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 wi
Sponsor: Ablon Skin Institute Research Center

Current Primary Outcome:

  • Number of terminal hairs in the target area of the scalp. [ Time Frame: 90 days ]
    The first primary efficacy parameter from the phototrichogram will be the number of terminal hairs in the target area of the scalp. Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of greater than 40 micrometers. Phototrichogram macrophotographs will be taken of the selected target area of each subject at each visit as specified under the Schedule of Procedures. Digital macrophotography will be performed using a Nikon Coolpix 4300 camera with a 3GEN Dermlite Foto37 system for scalp photography. The macrophotographs are then read by the investigator to determine the terminal hair count.
  • Number of vellus hairs in the target area of the scalp. [ Time Frame: 90 days ]
    The second primary efficacy parameter from the phototrichogram will be the number of vellus hairs in the target area of the scalp. Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers. Phototrichogram macrophotographs will be taken of the selected target area of each subject at each visit as specified under the Schedule of Procedures. Digital macrophotography will be performed using a Nikon Coolpix 4300 camera with a 3GEN Dermlite Foto37 system for scalp photography. The macrophotographs are then read by the investigator to determine the terminal hair count.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Dino-Lite microscopic photographs for terminal hair diameter measurements in the target area [ Time Frame: 90 days ]
    Dino-Lite Microscopic digital photographs to measure the diameter of the hair will be taken of the selected target area of each subject at each visit as specified under the Schedule of Procedures. Ten (10) terminal hairs in the target area will be randomly chosen throughout the area (not all from one direct area) and cut at the surface of the scalp thus not creating any bald patches. The hair diameter will then be measured at 1mm from the cut end of the hair. The ten (10) hair measurements will then be averaged to attain a median hair diameter for the target area.
  • Hair washing (shampooing) in clinic for hair shedding counts ( [ Time Frame: 90 days ]
    Subjects will be instructed to wash their hair at home 24 hours in advance of study visits 1 and 2. Subjects will then have their hair washed (shampooed) with Viviscal Gentle Shampoo in the office over a sink containing cheesecloth. 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 Subjects will have their hair washed and shedding hairs counted on Visits 1 and 2.
  • Quality of Life Questionnaire [ Time Frame: 90 days ]
    Questionnaire about the subjects general lifestyle and how their life is affected by thinning hair.
  • Self-Assessment Questionnaire [ Time Frame: 90 days ]
    Questionnaire is the evaluation of the growth and qualities related to the subjects hair, nails and skin.


Original Secondary Outcome: Same as current

Information By: Ablon Skin Institute Research Center

Dates:
Date Received: November 18, 2014
Date Started: August 2013
Date Completion:
Last Updated: November 19, 2014
Last Verified: November 2014