Status:
COMPLETED
Study Evaluating the Effects of Dietary Supplement on Hair Thickness and Hair Strength in Individuals with Self-Perceived Thinning Hair
Lead Sponsor:
Nutra Harmony LLC
Conditions:
Hair Thinning
Eligibility:
All Genders
21-50 years
Phase:
NA
Brief Summary
The Nutra Harmony "Biotin, Collagen \& Keratin Beauty Complex" is an oral food/dietary supplement specifically designed to promote hair growth for people suffering from temporary thinning hair. Th...
Detailed Description
This study was a two-arm, parallel group, double-blind, placebo-controlled trial powered to detect meaningful differences in the hair growth for people suffering from temporary thinning hair between t...
Eligibility Criteria
Inclusion
- Individuals, ages 21-50 years of age.
- Clinically-determined general good health as determined by responses to the initial study assessment.
- Individuals with self-perceived thinning hair associated with poor diet, stress, hormone influences.
- Individuals willing to maintain their normal hair shampooing frequency.
- Individuals willing to add the provided oral supplement to their current daily routine.
- Individuals 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.
- Individuals willing to undergo a physical exam to include height, weight, blood pressure, pulse, general physical findings, scalp exam and blood sample collection.
- Individuals with Fitzpatrick I-IV photo skin types.
- Willingness to have digital photography of the target area and scalp for hair counts at Visits 1, 2, 3, 4, 5, 6.
- Willingness to have their hair washed (shampooed) over a sink containing cheesecloth for hair shedding counts at Visit 1, 2, 3, 4, 5, 6.
- Willingness to maintain a consistent haircut and hair color throughout the 3-months 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 (i.e. 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, 3 ,4 ,5, 6).
- Provision of signed and dated informed consent form.
Exclusion
- Individuals with a known history of intolerance or allergy to fish, seafood/shellfish 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.
- Individuals with known stressful incident within the last six months (i.e. death in family, miscarriage).
- Individuals who are participating on any clinical research study 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.
- Individuals currently using light therapy to treat thinning hair.
- Individuals who have regularly used Rogaine (Minoxidil) within the last 3 months.
- Individuals currently using any other biotin/keratin/collagen supplements.
- Individuals 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).
- Individuals 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.
- Individuals with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
- Individuals 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 :
February 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06605768
Start Date
February 19 2024
End Date
August 30 2024
Last Update
September 20 2024
Active Locations (1)
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1
Limited Liability Company Treatment and Diagnostic Center ADONIS Plus
Kyiv, Ukraine