Clinical trial NCT03106792: A Clinical Trial to Evaluate the Effectiveness of Hairfinity on Improving Hair Health and Rate of Growth
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Participants
Lead sponsor: Brock Beauty Inc.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2017-04-10
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


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)

Primary outcomes:
measure: Rate of distal hair growth
timeFrame: 90 days
Secondary outcomes:
measure: Change in number of shed hair strands
timeFrame: 90 days
measure: Change in mean diameter of hair fibers
timeFrame: 90 days
measure: Change in hair density
timeFrame: 90 days
measure: Change in the number of terminal and vellus hairs
timeFrame: 90 days
measure: Changes in the percent of hairs in the anagen and telogen phases
timeFrame: 90 days
measure: Changes in hair quality parameters
timeFrame: 90 days
measure: Changes in hair quality
timeFrame: 90 days
measure: Changes in hair quality
timeFrame: 90 days
Other outcomes:
measure: Incidence of clinically significant abnormal vital signs
timeFrame: 90 days
measure: Incidence of clinically significant abnormal complete blood panel
timeFrame: 90 days
measure: Incidence of clinically significant abnormal electrolytes
timeFrame: 90 days
measure: Incidence of clinically significant abnormal kidney function panel
timeFrame: 90 days
measure: Incidence of clinically significant abnormal liver function panel
timeFrame: 90 days
measure: Incidence of adverse events
timeFrame: 90 days
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Tetyana Pelipyagina, MD
role: PRINCIPAL_INVESTIGATOR
References: