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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Dietary supplement: Hairfinity #1; Dietary supplement: Hairfinity #2; Dietary supplement: Hairfinity #3; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Female 18-50 years of age (inclusive)

2. 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
3. Fitzpatrick skin type of I-V (See appendix 3)
4. Willing to maintain the colour of and style of the hair cut for the duration of the study
5. Willing to maintain shampooing frequency and general hair regime for the duration of the study
6. Willing to not cut hair for the duration of the study
7. Willing to have area of hair prepped for Trichoscan analysis
8. Healthy as determined by laboratory results, medical history, and physical exam
9. Subjects must agree to comply with study procedures
10. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
2. Women who have begun hormonal birth control or hormone replacement within 6 months of randomization
3. Subjects taking natural health products, including multi-vitamins, botanicals and other nutraceuticals, within 2 weeks of randomization and for the duration of the study
4. 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)
5. Subjects having underwent a form of treatment for thinning hair, including prescription drugs or light therapy within 6 months of randomization
6. Medical history of diagnosed alopecia and/or trichotillomania (compulsive hair pulling). Medical history may be assessed by the Qualified Investigator
7. Subjects currently using hair extensions
8. 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
9. 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
10. Unstable medical condition as determined by qualified investigator
11. Clinically significant abnormal lab results at screening will be assessed by the Qualified Investigator
12. 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.
13. Alcohol abuse or drug abuse within the past 6 months
14. Consumption of greater than 2 standard alcoholic drinks per day
15. Use of medicinal marijuana
16. Participation in a clinical research trial within 30 days prior to randomization
17. Allergy or sensitivity to study product and/or it's ingredients
18. Individuals who are cognitively impaired and/or who are unable to give informed consent
19. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hairfinity #1; Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days	Dietary supplement: Hairfinity #1; Main Hairfinity formulation
EXPERIMENTAL: Hairfinity #2; Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days	Dietary supplement: Hairfinity #2; Variation to main formulation
EXPERIMENTAL: Hairfinity #3; Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days	Dietary supplement: Hairfinity #3; Variation to main formulation
PLACEBO_COMPARATOR: Placebo; Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days	Dietary supplement: Placebo; No active ingredients

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Brock Beauty Inc.
• Collaborators: KGK Science Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 24, 2017
• Primary Completion (ACTUAL): June 29, 2018
• Study Completion (ACTUAL): June 29, 2018

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (ACTUAL): April 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 16HHHB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No