Clinical Trial: Efficacy of the New Viviscal Professional Strength Oral Supplement in Females With Thinning Hair

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

Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy of the New Viviscal Professional Strength Oral Supplement in Females With Self-Perceived Thinning H

Brief 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 Summary:

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
Sponsor: Ablon Skin Institute Research Center

Current Primary Outcome:

• Number of terminal hairs in the target area of the scalp. [ Time Frame: 180 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: 180 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 vellus 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: 180 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.
• Quality of Life Questionnaire [ Time Frame: 180 days ]
  Questionnaire about the subjects general lifestyle and how their life is affected by thinning hair.
• Self-Assessment Questionnaire [ Time Frame: 180 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 24, 2014
Date Started: February 2013
Date Completion:
Last Updated: November 25, 2014
Last Verified: November 2014