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

NCT02288858 | Completed

• 1 other identifier: L2G-Stephens-Viviscal
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Hair Thinning

Keywords

Hair thinning

Outcome Measures

Primary Outcomes (2)

• Hair shedding rate

  The numbers of scalp hairs shed at month 3 and month 6 when compared with baseline values.

  6 months

• Hair fiber diameter

  Mean vellus hair width change

  6 months

Secondary Outcomes (1)

• Quality of life questionnaires

  6 months

Study Arms (2)

Test product

ACTIVE COMPARATOR

Viviscal Oral Supplement Tablets (as 512mg coated red-brown tablets in unbranded blister packs)

Dietary Supplement: Viviscal Oral Supplement Tablets

Placebo

PLACEBO COMPARATOR

Placebo Tablets (as 512 coated red-brown tablets in unbranded blister packs)

Dietary Supplement: Viviscal Oral Supplement Tablets

Interventions

Viviscal Oral Supplement Tablets DIETARY_SUPPLEMENT

Tablet (512 mg)

Placebo; Test product

Eligibility Criteria

• Age: 24 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females, ages 21-55 years of age.
• Clinically-determined general good health as determined by responses to the initial paperwork.
• Females with self-perceived thinning hair associated with poor diet, stress, hormone influences or abnormal menstrual cycle.
• Females willing to maintain their normal hair shampooing frequency.
• Females willing to add the provided oral supplement to their current daily routine.
• Females willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible.
• Females willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, general physical findings and a scalp exam. The physical exam will occur at Visits 1, 3, and 5.
• Females willing to have a small dot tattoo applied to the scalp, a small area of hair shaved (approximately 1 cm2) to approximately 1 mm in length, remaining hair in that small area dyed black, and to have photographs performed. If the dot tattoo fades substantially by Visit 3, it may need to be re-inked.
• Females willing to wash their hair at the testing facility at Visits 2, 4 and 6 with the provided normal shampoo. Subjects may bring their own conditioner to use after shampooing.
• Individuals with Fitzpatrick I-III photo skin types, (Fitzpatrick IV may be enrolled at the discretion of the clinical investigator).
• Willingness to maintain a consistent haircut and hair color throughout the 6 month study period.

You may not qualify if:

• Females with a known history of intolerance or allergy to fish, seafood or acerola.
• Individuals with any known allergy or sensitivity to any shampoo/conditioner.
• Females who are nursing, pregnant, planning to become pregnant during the study.
• Females who are participating on any clinical research study at Stephens or at another research center or doctor's office.
• Females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study.
• Females currently using the HairMax light treatment to treat thinning hair.
• Females who have regularly used Rogaine (Minoxidil) or Nizoral/Ketoconazole within the last 3 months.
• Females who have used prescription drugs known to affect the hair growth cycle within, 6 months (e.g., hormone-based birth control for less than 6 months).
• Females suffering from other hair loss disorders, such as alopecia areata, scarring alopecia or androgenetic alopecia.
• Females who have had hair transplants within 6 months of study start.
• Individuals with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc. Medical conditions that are under control with or without treatment will be considered on an individual basis by the Investigators.
• Females with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
• Females having a known active dermatologic condition which, in the opinion of the examining Investigator, might place the subject at a greater risk or interfere with clinical evaluations (e.g., seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.)

Sponsors & Collaborators

• Irish Response t/a Lifes2good: lead
• Stephens & Associates, Inc.: collaborator

Study Sites (1)

Stephens Associates Inc.

Richardson, Texas, 75081, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald L Rizer, PhD

  Stephens & Associates, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 11, 2014
• Study Start: April 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

US (1)