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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106792
• Other study ID #: 16HHHB
• Status: Completed
• Phase: Phase 2
• Start date: July 24, 2017
• Est. completion date: June 29, 2018

Study information

• Verified date: July 2018
• Source: Brock Beauty Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Dietary Supplement:
• Hairfinity #1
Main Hairfinity formulation
• Hairfinity #2
Variation to main formulation
• Hairfinity #3
Variation to main formulation
• Placebo
No active ingredients

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Brock Beauty Inc.	KGK Synergize Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of clinically significant abnormal vital signs		90 days
Other	Incidence of clinically significant abnormal complete blood panel		90 days
Other	Incidence of clinically significant abnormal electrolytes		90 days
Other	Incidence of clinically significant abnormal kidney function panel		90 days
Other	Incidence of clinically significant abnormal liver function panel		90 days
Other	Incidence of adverse events		90 days
Primary	Rate of distal hair growth	assessed using Trichoscan HD	90 days
Secondary	Change in number of shed hair strands	assessed using the standardized wash test	90 days
Secondary	Change in mean diameter of hair fibers	assessed using Trichoscan HD	90 days
Secondary	Change in hair density	assessed using Trichoscan HD	90 days
Secondary	Change in the number of terminal and vellus hairs	assessed using Trichoscan HD	90 days
Secondary	Changes in the percent of hairs in the anagen and telogen phases	assessed using Trichoscan HD	90 days
Secondary	Changes in hair quality parameters	assessed by a dermatologist	90 days
Secondary	Changes in hair quality	assessed by a dermatologist	90 days
Secondary	Changes in hair quality	assessed with self-assessment questionnaires	90 days