HealthyNCT03659994
Effects of VitaBeard® on Facial Hair Growth in Healthy Adult Men
A study testing Multivitamin in people with Healthy, run by Do Vitamins Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to determine dose-dependent effects of Vitabeard on various parameters of facial hair growth. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Jun 2017
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male aged 18 - 40 (inclusive)
- Healthy as determined from medical history
- Fitzpatrick skin type I-IV (See Appendix 1) with dark facial hair (brown or black)
- Non-smoker, or who quit smoking ≥6 months prior to visit 1
- Body mass index 18.0 - 29.9 kg/m2 (inclusive)
- Willing to avoid alcohol consumption 24 hours prior to the clinic visit and during the two 5-day assessment periods of facial hair growth
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- Willing to maintain a stable body weight, activity level, sexual activity levels and dietary patterns, except for use of the study products, as directed
- Willing to maintain current outdoor activity amounts
- Willing to maintain current sexual activity level
- Willing to maintain current sleep habits
- Agrees to maintain current shaving habits during the study period with the exception of the assessment periods, during which participant agrees to avoid shaving
- Willing and able to provide consent for photographic release
- Willing and able to provide informed written consent
Who cannot join
- Individuals taking prescription or non-prescription health products that may affect the study endpoint in 6 months prior to visit 1 or during the study, such as hormone replacement therapy (testosterone, estrogen, progesterone, etc.), anabolic steroids, chemotherapy, intravenous or oral B vitamins, 5α-reductase inhibitors (e.g minoxidil, finasteride, etc.), medications with anti-androgenic properties (e.g. cyproterone, pironolacotne, ketoconazole, flutamide, bicalutamide), medications that can potentially cause hypertrichosis (e.g. ciclosporin, diazoxide, phenytoin, psoralens), oral glucocorticoids (inhaled glucocorticoids are permitted), lithium or phenothiazines, medications of known or suspected photoxocity (e.g., tetracyclines, thiazides, certain NSAIDs) and any other medications which, in the opinion of the investigator, may interfere with the performance of study assessments or place the subject at undue risk.
- Use of sulfonamides within 3 months prior to visit 1
- Unstable use (i.e. initiation or change in dose) medications for a thyroid condition within 3 months prior to visit 1
- Use of multivitamins within 2 weeks prior to visit 2a
- Use of Vitamin D containing supplements (≥500IU/day) within 4 weeks prior to visit 2a
- Use of Vitamin B7 (Biotin) containing supplements within 1 week prior to visit 2a
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- Use of facial hair dyes (e.g. Just for Men®) in the previous 3 months and during the study
- Current use of depilatories, waxing, plucking or bleaching or current or prior use at any time of laser hair removal on the target test or surrounding area to an extent which, in the opinion of the investigator, may interfere with the performance of the study assessments
- Very little contrast between hair color and scalp (e.g., fair-haired with an extremely pale skin color)
- Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 6 months prior to visit 1 and throughout the study
- Individuals with an outdoor occupation (e.g. landscaper, surveyor, outdoor construction, etc.)
- Active skin diseases (e.g. eczema, atopic dermatitis, psoriasis, skin cancer, sun damaged skin with actinic keratosis, on facial/chin area)
- Damaged skin in or around test site including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test site
- Routine high dosage use of anti-inflammatory medications (such as aspirin, ibuprofen, corticosteroids, etc), immunosuppressive drugs or antihistamine medications. Steroid nose drops and/or eye drops are permitted. Two 81mg or one 325mg aspirin per day is also permitted.
- Use of topical drugs on the face or underneath chin area
- History of disorders affecting biotin metabolism (e.g. holocarboxylase synthetase (HCS) deficiency, biotinidase deficiency, biotin-responsive basal ganglia disease, multiple carboxylase deficiency)
- Presence of major diseases such as diabetes, gastrointestinal, endocrine, cardiovascular, renal, or liver disease
- History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.)
- History of cancer in the past 5 years
- Uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
- Abnormal laboratory test results of clinical significance, including, but not limited to ALT or AST ≥1.5X the upper limit of normal at screening (Visit 1)
- Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of >2 standard alcoholic drinks per day
- Participant has a known allergy or intolerance to any of the ingredients in the test product or placebo
- Participant is unwilling or unable to abide by the requirements of the protocol
- Any condition that would interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study, or put the participant at risk
- Participant has taken an investigational medicine or has participated in a research study within 30 days prior to first study visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Clinical Trial to Compare the Effects of VitaBeard® on Facial Hair Growth in Healthy Adult Men
The purpose of this study is to determine dose-dependent effects of Vitabeard on various parameters of facial hair growth.
Read the detailed description
Primary and secondary assessments of efficacy will be made based on information obtained through hair measurements using Dermoscan and Trichoscan smart software. The device includes a camera handpiece with 5MP USB high resolution camera (Full HD) for standardized images and reproducible measurements. The Trichoscan smart software will be used for the measurement of hair parameters including hair count, hair density, hair width and hair length. Each subject will receive a permanent ink marking underneath the chin to standardize the location of assessments. Assessment periods over a 5 day period prior to baseline and a 5-day period at the end of the study. On the first day of each period, subjects will shave in the clinic and image is capture to demonstrate the clean shave of the area (Day 0), subjects do not shave for the following 5-days and images will be taken on Days 2 and 5 of each assessment period. Day 5 values will be used for comparing supplement effects (baseline to end of study, between groups). Day 2 will be used to calculate rate of growth during each assessment period, and will be used to compare supplement effects (baseline to end of study, between groups).
- Conditions
- Healthy
- Being tested
- Multivitamin, Placebo
- Keywords
- Facial Hair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultivitaminDietary supplement
Vitabeard
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitabeard High Dose | Experimental | 3 capsules of multivitamin Vitabeard Receives: Dietary Supplement: Multivitamin |
| Vitabeard Mid-Dose | Experimental | 2 Capsules of multivitamin Vitabeard, 1 Capsule of Placebo Receives: Dietary Supplement: Multivitamin |
| Vitabeard Low-Dose | Experimental | 1 Capsule of multivitamin Vitabeard, 2 Capsules of Placebo Receives: Dietary Supplement: Multivitamin |
| Placebo | Placebo comparator | 3 Capsules of Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Facial Hair Growth
Rate of hair growth will be determined as the change in length of hair from day 2 to day 5 of each assessment period (beginning of study and end of study) divided by the number of days. Hair length was obtained using Trichoscan software and images captured with Dermoscan
Measured: 33 Days
Secondary outcomes (2)
Facial hair density
Determined as the number of hairs in a standardized area calculated automatically by Trichoscan software and images captured with Dermoscan
Measured: 33 days
Facial hair strand thickness
Hair width determined automatically using Trichoscan software and images captured with Dermoscan
Measured: 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study startJan 2017
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Do Vitamins Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659994
- Sponsor's protocol ID
- 1050-003-PRO-10072015
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Clinical Trial to Compare the Effects of VitaBeard® on Facial Hair Growth in Healthy Adult Men
- ClinicalTrials.gov ID
- NCT03659994
- Acronym / sponsor ID
- 1050-003-PRO-10072015
- Conditions
- Healthy
- Keywords
- Facial Hair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Do Vitamins Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Sep 2018 (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 purpose of this study is to determine dose-dependent effects of Vitabeard on various parameters of facial hair growth.
Detailed description
Primary and secondary assessments of efficacy will be made based on information obtained through hair measurements using Dermoscan and Trichoscan smart software. The device includes a camera handpiece with 5MP USB high resolution camera (Full HD) for standardized images and reproducible measurements. The Trichoscan smart software will be used for the measurement of hair parameters including hair count, hair density, hair width and hair length. Each subject will receive a permanent ink marking underneath the chin to standardize the location of assessments. Assessment periods over a 5 day period prior to baseline and a 5-day period at the end of the study. On the first day of each period, subjects will shave in the clinic and image is capture to demonstrate the clean shave of the area (Day 0), subjects do not shave for the following 5-days and images will be taken on Days 2 and 5 of each assessment period. Day 5 values will be used for comparing supplement effects (baseline to end of study, between groups). Day 2 will be used to calculate rate of growth during each assessment period, and will be used to compare supplement effects (baseline to end of study, between groups).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitabeard High Dose | Experimental | Dietary Supplement: Multivitamin3 capsules of multivitamin Vitabeard |
| Vitabeard Mid-Dose | Experimental | Dietary Supplement: Multivitamin2 Capsules of multivitamin Vitabeard, 1 Capsule of Placebo |
| Vitabeard Low-Dose | Experimental | Dietary Supplement: Multivitamin1 Capsule of multivitamin Vitabeard, 2 Capsules of Placebo |
| Placebo | Placebo comparator | Dietary Supplement: Placebo3 Capsules of Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male aged 18 - 40 (inclusive)
- Healthy as determined from medical history
- Fitzpatrick skin type I-IV (See Appendix 1) with dark facial hair (brown or black)
- Non-smoker, or who quit smoking ≥6 months prior to visit 1
- Body mass index 18.0 - 29.9 kg/m2 (inclusive)
Key exclusion criteria (26 listed)
- Individuals taking prescription or non-prescription health products that may affect the study endpoint in 6 months prior to visit 1 or during the study, such as hormone replacement therapy (testosterone, estrogen, progesterone, etc.), anabolic steroids, chemotherapy, intravenous or oral B vitamins, 5α-reductase inhibitors (e.g minoxidil, finasteride, etc.), medications with anti-androgenic properties (e.g. cyproterone, pironolacotne, ketoconazole, flutamide, bicalutamide), medications that can potentially cause hypertrichosis (e.g. ciclosporin, diazoxide, phenytoin, psoralens), oral glucocorticoids (inhaled glucocorticoids are permitted), lithium or phenothiazines, medications of known or suspected photoxocity (e.g., tetracyclines, thiazides, certain NSAIDs) and any other medications which, in the opinion of the investigator, may interfere with the performance of study assessments or place the subject at undue risk.
- Use of sulfonamides within 3 months prior to visit 1
- Unstable use (i.e. initiation or change in dose) medications for a thyroid condition within 3 months prior to visit 1
- Use of multivitamins within 2 weeks prior to visit 2a
- Use of Vitamin D containing supplements (≥500IU/day) within 4 weeks prior to visit 2a
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 |
|---|---|---|
| MultivitaminVitabeard | Dietary supplement | Vitabeard High Dose, Vitabeard Low-Dose, Vitabeard Mid-Dose |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Rate of Facial Hair Growth
Time frame: 33 Days
Rate of hair growth will be determined as the change in length of hair from day 2 to day 5 of each assessment period (beginning of study and end of study) divided by the number of days. Hair length was obtained using Trichoscan software and images captured with Dermoscan
2 secondary outcomes
Facial hair density
Time frame: 33 days
Facial hair strand thickness
Time frame: 33 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 6 Sep 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamin in people with Healthy, run by Do Vitamins 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 13 inclusion and 26 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 6 Sep 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.
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 Facial Hair Growth (time frame: 33 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 6 Sep 2018.