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

NCT03106792 | Completed Phase 2

• 1 other identifier: 16HHHB
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of distal hair growth

  assessed using Trichoscan HD

  90 days

Secondary Outcomes (8)

• Change in number of shed hair strands

  90 days

• Change in mean diameter of hair fibers

  90 days

• Change in hair density

  90 days

• Change in the number of terminal and vellus hairs

  90 days

• Changes in the percent of hairs in the anagen and telogen phases

  90 days

Other Outcomes (6)

• 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

Study Arms (4)

Hairfinity #1

EXPERIMENTAL

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

Dietary Supplement: Hairfinity #1

Hairfinity #2

EXPERIMENTAL

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

Dietary Supplement: Hairfinity #2

Hairfinity #3

EXPERIMENTAL

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

Dietary Supplement: Hairfinity #3

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Hairfinity #1 DIETARY_SUPPLEMENT

Main Hairfinity formulation

Hairfinity #1

Hairfinity #2 DIETARY_SUPPLEMENT

Variation to main formulation

Hairfinity #2

Hairfinity #3 DIETARY_SUPPLEMENT

Variation to main formulation

Hairfinity #3

Placebo DIETARY_SUPPLEMENT

No active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female 18-50 years of age (inclusive)
• 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).
• 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
• Fitzpatrick skin type of I-V (See appendix 3)
• Willing to maintain the colour of and style of the hair cut for the duration of the study
• Willing to maintain shampooing frequency and general hair regime for the duration of the study
• Willing to not cut hair for the duration of the study
• Willing to have area of hair prepped for Trichoscan analysis
• Healthy as determined by laboratory results, medical history, and physical exam
• Subjects must agree to comply with study procedures

You may not qualify if:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
• Women who have begun hormonal birth control or hormone replacement within 6 months of randomization
• Subjects taking natural health products, including multi-vitamins, botanicals and other nutraceuticals, within 2 weeks of randomization and for the duration of the study
• 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)
• Subjects having underwent a form of treatment for thinning hair, including prescription drugs or light therapy within 6 months of randomization
• Medical history of diagnosed alopecia and/or trichotillomania (compulsive hair pulling). Medical history may be assessed by the Qualified Investigator
• Subjects currently using hair extensions
• 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
• 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
• Unstable medical condition as determined by qualified investigator
• Clinically significant abnormal lab results at screening will be assessed by the Qualified Investigator
• 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.
• Alcohol abuse or drug abuse within the past 6 months
• Consumption of greater than 2 standard alcoholic drinks per day
• Use of medicinal marijuana

Sponsors & Collaborators

• Brock Beauty Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: July 24, 2017
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

CA (1)