Healthy ParticipantsPhase 2NCT03106792
A Clinical Trial to Evaluate the Effectiveness of Hairfinity on Improving Hair Health and Rate of Growth
A Phase 2 study testing Hairfinity #1, Hairfinity #2 and Hairfinity #3 in people with Healthy Participants, run by Brock Beauty Inc. at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Hairfinity #1, Hairfinity #2 and Hairfinity #3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jul 2017to 29 Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- 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
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- 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
- Has given voluntary, written, informed consent to participate in the study
Who cannot join
- 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
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- 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
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study product and/or it's ingredients
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Hairfinity #1, Hairfinity #2, Hairfinity #3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hairfinity #1Dietary supplement
Main Hairfinity formulation
Hairfinity #2Dietary supplement
Variation to main formulation
Hairfinity #3Dietary supplement
Variation to main formulation
PlaceboDietary supplement
No active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Hairfinity #1 | Experimental | Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of distal hair growth
assessed using Trichoscan HD
Measured: 90 days
Secondary outcomes (8)
Change in number of shed hair strands
assessed using the standardized wash test
Measured: 90 days
Change in mean diameter of hair fibers
assessed using Trichoscan HD
Measured: 90 days
Change in hair density
assessed using Trichoscan HD
Measured: 90 days
Change in the number of terminal and vellus hairs
assessed using Trichoscan HD
Measured: 90 days
Changes in the percent of hairs in the anagen and telogen phases
assessed using Trichoscan HD
Measured: 90 days
Changes in hair quality parameters
assessed by a dermatologist
Measured: 90 days
Changes in hair quality
assessed by a dermatologist
Measured: 90 days
Changes in hair quality
assessed with self-assessment questionnaires
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start24 Jul 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock Beauty Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106792
- Sponsor's protocol ID
- 16HHHB
- Status last verified
- Jul 2018
- First submitted
- 4 Apr 2017
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03106792
- Acronym / sponsor ID
- 16HHHB
- Conditions
- Healthy Participants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Brock Beauty Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hairfinity #1 | Experimental | Dietary Supplement: Hairfinity #1Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days |
| Hairfinity #2 | Experimental | Dietary Supplement: Hairfinity #2Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days |
| Hairfinity #3 | Experimental | Dietary Supplement: Hairfinity #3Dosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDosage form: Capsule Frequency: Take 2 capsules by mouth in the morning with a meal. Duration: 90 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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).
- 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:
- Fitzpatrick skin type of I-V (See appendix 3)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hairfinity #1Main Hairfinity formulation | Dietary supplement | Hairfinity #1 |
| Hairfinity #2Variation to main formulation | Dietary supplement | Hairfinity #2 |
| Hairfinity #3Variation to main formulation | Dietary supplement | Hairfinity #3 |
| PlaceboNo active ingredients | Dietary supplement | Placebo |
Primary outcome
Rate of distal hair growth
Time frame: 90 days
assessed using Trichoscan HD
8 secondary outcomes
Change in number of shed hair strands
Time frame: 90 days
Change in mean diameter of hair fibers
Time frame: 90 days
Change in hair density
Time frame: 90 days
Change in the number of terminal and vellus hairs
Time frame: 90 days
Changes in the percent of hairs in the anagen and telogen phases
Time frame: 90 days
Changes in hair quality parameters
Time frame: 90 days
Changes in hair quality
Time frame: 90 days
Changes in hair quality
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetyana Pelipyagina, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hairfinity #1, Hairfinity #2 and Hairfinity #3 in people with Healthy Participants, run by Brock Beauty Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of distal hair growth (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.