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

NCT ID: NCT03106792

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2018-06-29

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).

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Hairfinity #1

Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days

Group Type: EXPERIMENTAL

Hairfinity #1

Intervention Type: DIETARY_SUPPLEMENT

Main Hairfinity formulation

Hairfinity #2

Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days

Group Type: EXPERIMENTAL

Hairfinity #2

Intervention Type: DIETARY_SUPPLEMENT

Variation to main formulation

Hairfinity #3

Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days

Group Type: EXPERIMENTAL

Hairfinity #3

Intervention Type: DIETARY_SUPPLEMENT

Variation to main formulation

Placebo

Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

No active ingredients

Interventions

Hairfinity #1

Main Hairfinity formulation

Intervention Type: DIETARY_SUPPLEMENT

Hairfinity #2

Variation to main formulation

Intervention Type: DIETARY_SUPPLEMENT

Hairfinity #3

Variation to main formulation

Intervention Type: DIETARY_SUPPLEMENT

Placebo

No active ingredients

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

Brock Beauty Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tetyana Pelipyagina, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Synergize Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

16HHHB

Identifier Type: -

Identifier Source: org_study_id