A Clinical Trial to Evaluate the Effectiveness of Hairfinity on Improving Hair Health and Rate of Growth

Study Overview
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Brief Summary
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The primary outcome of the study is the effect of Hairfinity vs. Placebo on the rate of distal hair growth, assessed using Trichoscan HD, in healthy female adults from baseline to day 90 (end of study).

Official Title
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A Randomized, Double-blind, Placebo-controlled, 4-arm Parallel Study to Evaluate the Effectiveness of Hairfinity on Improving Hair Health and Rate of Growth

Conditions
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Healthy Participants

Intervention / Treatment
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* Dietary Supplement: Hairfinity #1
* Dietary Supplement: Hairfinity #2
* Dietary Supplement: Hairfinity #3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18-50 years of age (inclusive) Subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation). OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) Intrauterine devices Vasectomy of partner Double Barrier Method Non-heterosexual lifestyle Fitzpatrick skin type of I-V (See appendix 3) Willing to maintain the colour of and style of the hair cut for the duration of the study Willing to maintain shampooing frequency and general hair regime for the duration of the study Willing to not cut hair for the duration of the study Willing to have area of hair prepped for Trichoscan analysis Healthy as determined by laboratory results, medical history, and physical exam Subjects must agree to comply with study procedures Has given voluntary, written, informed consent to participate in the study Exclusion Criteria: Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial. Women who have begun hormonal birth control or hormone replacement within 6 months of randomization Subjects taking natural health products, including multi-vitamins, botanicals and other nutraceuticals, within 2 weeks of randomization and for the duration of the study Subjects with Fitzpatrick scores over V, which stems from the sensitivity of the testing method (requires a degree of color contrast when evaluating hair relative to skin) Subjects having underwent a form of treatment for thinning hair, including prescription drugs or light therapy within 6 months of randomization Medical history of diagnosed alopecia and/or trichotillomania (compulsive hair pulling). Medical history may be assessed by the Qualified Investigator Subjects currently using hair extensions Subjects with psoriasis or any active dermatological condition of the scalp at randomization that in the opinion of the qualified investigator would interfere with the clinical evaluations Medical history of thyroid disorders or with TSH levels outside the normal range (0.4-4.5 ±0.05) as assessed by the Qualified Investigator Unstable medical condition as determined by qualified investigator Clinically significant abnormal lab results at screening will be assessed by the Qualified Investigator History, or current diagnosis of any cancer (except for successfully treated basal cell carcinoma in an area other than the scalp) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years of diagnosis are acceptable. Alcohol abuse or drug abuse within the past 6 months Consumption of greater than 2 standard alcoholic drinks per day Use of medicinal marijuana Participation in a clinical research trial within 30 days prior to randomization Allergy or sensitivity to study product and/or it's ingredients Individuals who are cognitively impaired and/or who are unable to give informed consent Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject (e.g. cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders etc)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hairfinity #1<br>Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days | Dietary Supplement: Hairfinity #1<br>* Main Hairfinity formulation<br>|
| Experimental: Hairfinity #2<br>Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days | Dietary Supplement: Hairfinity #2<br>* Variation to main formulation<br>|
| Experimental: Hairfinity #3<br>Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days | Dietary Supplement: Hairfinity #3<br>* Variation to main formulation<br>|
| Placebo Comparator: Placebo<br>Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days | Dietary Supplement: Placebo<br>* No active ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of distal hair growth | assessed using Trichoscan HD | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of shed hair strands | assessed using the standardized wash test | 90 days | 
| Change in mean diameter of hair fibers | assessed using Trichoscan HD | 90 days | 
| Change in hair density | assessed using Trichoscan HD | 90 days | 
| Change in the number of terminal and vellus hairs | assessed using Trichoscan HD | 90 days | 
| Changes in the percent of hairs in the anagen and telogen phases | assessed using Trichoscan HD | 90 days | 
| Changes in hair quality parameters | assessed by a dermatologist | 90 days | 
| Changes in hair quality | assessed by a dermatologist | 90 days | 
| Changes in hair quality | assessed with self-assessment questionnaires | 90 days |