Effects of VitaBeard® on Facial Hair Growth in Healthy Adult Men

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Multivitamin

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G0B4
      • Nutrasource

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitabeard High Dose; 3 capsules of multivitamin Vitabeard	Dietary supplement: Multivitamin; Vitabeard
Experimental: Vitabeard Mid-Dose; 2 Capsules of multivitamin Vitabeard, 1 Capsule of Placebo	Dietary supplement: Multivitamin; Vitabeard
Experimental: Vitabeard Low-Dose; 1 Capsule of multivitamin Vitabeard, 2 Capsules of Placebo	Dietary supplement: Multivitamin; Vitabeard
Placebo Comparator: Placebo; 3 Capsules of Placebo	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	33 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial hair density	Determined as the number of hairs in a standardized area calculated automatically by Trichoscan software and images captured with Dermoscan	33 days
Facial hair strand thickness	Hair width determined automatically using Trichoscan software and images captured with Dermoscan	33 days

Collaborators and Investigators

• Sponsor: Do Vitamins Inc.
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Facial Hair
• Other Study ID Numbers: 1050-003-PRO-10072015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No