Status:
COMPLETED
Viviscal Extra-Strength Formulation To Promote Hair Growth And Decrease Shedding In Women With Thinning Hair
Lead Sponsor:
Ablon Skin Institute Research Center
Collaborating Sponsors:
Irish Response t/a Lifes2good
Conditions:
Hair Thinning
Eligibility:
FEMALE
21-65 years
Phase:
NA
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 o...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Females, ages 21-65 years of age
- Clinically-determined general good health as determined by responses to the initial study assessment
- Females with self-perceived thinning hair associated with poor diet, stress, hormone influences or abnormal menstrual cycle as determined on initial study assessment by the Investigator (This will not include patients with medically diagnosed telogen effluvium)
- 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 and 2
- Females with Fitzpatrick I-IV photo skin types
- Willingness to have digital photography of the target area and scalp for hair counts at Visits 1 and 2
- Willingness to have ten (10) terminal hairs from the target area cut at the base of the scalp for microscopic hair measurements at Visits 1 and 2
- Willingness to have their hair washed (shampooed) with Viviscal Gentle Shampoo over a sink containing cheesecloth for hair shedding counts at Visits 1 and 2
- Willingness to maintain a consistent hair cut and hair color throughout the 3 month study period and to come to visits with clean (shampoo must be done 24 hours or more prior to the visit) and dry hair
- Willingness of subjects who have color treated hair 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 Visit 2)
Exclusion
- Females with a known history of intolerance or allergy to fish, seafood/shellfish or acerola
- Females with any known allergy or sensitivity to any shampoo/conditioner
- Females who are nursing, pregnant, planning to become pregnant during the study
- Females with known stressful incident within the last six months (ie. death in family, miscarriage)
- Females who are participating on any clinical research study at ASIRC 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 or other light therapy to treat thinning hair
- Females who have regularly used Rogaine (Minoxidil) within the last 3 months
- Females who have used prescription drugs known to affect the hair growth cycle within the last 6 months (e.g., hormone-based birth control for less than 6 months, cyproterone acetate, aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor)
- Females suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined on initial study assessment by the Investigator
- 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 Investigators, 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 :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02297360
Start Date
August 1 2013
End Date
April 1 2014
Last Update
November 21 2014
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