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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hairfinity #1 | Experimental | Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days |
|
| Hairfinity #2 | Experimental | Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days |
|
| Hairfinity #3 | Experimental | Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days |
|
| Placebo | Placebo Comparator | Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hairfinity #1 | Dietary Supplement | Main Hairfinity formulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of distal hair growth | assessed using Trichoscan HD | 90 days |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically significant abnormal vital signs | 90 days | |
| Incidence of clinically significant abnormal complete blood panel | 90 days | |
| Incidence of clinically significant abnormal electrolytes |
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Pelipyagina, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| Hairfinity #2 |
| Dietary Supplement |
Variation to main formulation |
|
| Hairfinity #3 | Dietary Supplement | Variation to main formulation |
|
| Placebo | Dietary Supplement | No active ingredients |
|
| 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 |
| 90 days |
| Incidence of clinically significant abnormal kidney function panel | 90 days |
| Incidence of clinically significant abnormal liver function panel | 90 days |
| Incidence of adverse events | 90 days |