Status:
COMPLETED
To Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair
Lead Sponsor:
Irish Response t/a Lifes2good
Collaborating Sponsors:
Stephens & Associates, Inc.
Conditions:
Hair Thinning
Eligibility:
All Genders
24-55 years
Phase:
NA
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 placeb...
Detailed Description
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 placeb...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.)
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT02288858
Start Date
April 1 2011
End Date
November 1 2011
Last Update
November 14 2014
Active Locations (1)
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1
Stephens Associates Inc.
Richardson, Texas, United States, 75081