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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03106792
• Date of registration: 04/04/2017
• Prospective Registration: Yes
• Primary sponsor: Brock Beauty Inc.
• Public title: A Clinical Trial to Evaluate the Effectiveness of Hairfinity on Improving Hair Health and Rate of Growth
• Scientific 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
• Date of first enrolment: July 24, 2017
• Target sample size: 152
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03106792
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Tetyana Pelipyagina, MD
• Affiliation: KGK Science Inc.

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Healthy Participants

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Hairfinity #3

Dietary Supplement: Hairfinity #1

Dietary Supplement: Hairfinity #2

Primary Outcome(s)

Rate of distal hair growth [Time Frame: 90 days]

Secondary Outcome(s)

Change in hair density [Time Frame: 90 days]

Change in number of shed hair strands [Time Frame: 90 days]

Change in mean diameter of hair fibers [Time Frame: 90 days]

Changes in hair quality parameters [Time Frame: 90 days]

Change in the number of terminal and vellus hairs [Time Frame: 90 days]

Changes in hair quality [Time Frame: 90 days]

Changes in the percent of hairs in the anagen and telogen phases [Time Frame: 90 days]

Secondary ID(s)

16HHHB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

KGK Science Inc.