ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03106792
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
Brock Beauty Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Participants Dietary Supplement: Hairfinity #1 Dietary Supplement: Hairfinity #2 Dietary Supplement: Hairfinity #3 Dietary Supplement: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Placebo-controlled, 4-arm Parallel Study to Evaluate the Effectiveness of Hairfinity on Improving Hair Health and Rate of Growth
Actual Study Start Date : July 24, 2017
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018

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




Primary Outcome Measures :
  1. Rate of distal hair growth [ Time Frame: 90 days ]
    assessed using Trichoscan HD


Secondary Outcome Measures :
  1. Change in number of shed hair strands [ Time Frame: 90 days ]
    assessed using the standardized wash test

  2. Change in mean diameter of hair fibers [ Time Frame: 90 days ]
    assessed using Trichoscan HD

  3. Change in hair density [ Time Frame: 90 days ]
    assessed using Trichoscan HD

  4. Change in the number of terminal and vellus hairs [ Time Frame: 90 days ]
    assessed using Trichoscan HD

  5. Changes in the percent of hairs in the anagen and telogen phases [ Time Frame: 90 days ]
    assessed using Trichoscan HD

  6. Changes in hair quality parameters [ Time Frame: 90 days ]
    assessed by a dermatologist

  7. Changes in hair quality [ Time Frame: 90 days ]
    assessed by a dermatologist

  8. Changes in hair quality [ Time Frame: 90 days ]
    assessed with self-assessment questionnaires


Other Outcome Measures:
  1. Incidence of clinically significant abnormal vital signs [ Time Frame: 90 days ]
  2. Incidence of clinically significant abnormal complete blood panel [ Time Frame: 90 days ]
  3. Incidence of clinically significant abnormal electrolytes [ Time Frame: 90 days ]
  4. Incidence of clinically significant abnormal kidney function panel [ Time Frame: 90 days ]
  5. Incidence of clinically significant abnormal liver function panel [ Time Frame: 90 days ]
  6. Incidence of adverse events [ Time Frame: 90 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106792


Locations
Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
Brock Beauty Inc.
KGK Science Inc.
Investigators
Principal Investigator: Tetyana Pelipyagina, MD KGK Science Inc.

Responsible Party: Brock Beauty Inc.
ClinicalTrials.gov Identifier: NCT03106792     History of Changes
Other Study ID Numbers: 16HHHB
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No