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

• ClinicalTrials.gov Identifier: NCT03659994
• Recruitment Status: Completed
• First Posted: September 6, 2018
• Last Update Posted: September 6, 2018
• Sponsor: Do Vitamins Inc.
• Collaborator: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Information provided by (Responsible Party): Do Vitamins Inc.

Tracking Information

• First Submitted Date: September 4, 2018
• First Posted Date: September 6, 2018
• Last Update Posted Date: September 6, 2018
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 4, 2018)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 4, 2018)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of VitaBeard® on Facial Hair Growth in Healthy Adult Men
• Official Title: A Randomized, Double-blind, Clinical Trial to Compare the Effects of VitaBeard® on Facial Hair Growth in Healthy Adult Men
• Brief Summary: 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Other
• Condition: Healthy

Intervention

• Dietary Supplement: Multivitamin
  Vitabeard
• Dietary Supplement: Placebo
  Placebo

Study Arms

• Experimental: Vitabeard High Dose
  3 capsules of multivitamin Vitabeard
  Intervention: Dietary Supplement: Multivitamin
• Experimental: Vitabeard Mid-Dose
  2 Capsules of multivitamin Vitabeard, 1 Capsule of Placebo
  Intervention: Dietary Supplement: Multivitamin
• Experimental: Vitabeard Low-Dose
  1 Capsule of multivitamin Vitabeard, 2 Capsules of Placebo
  Intervention: Dietary Supplement: Multivitamin
• Placebo Comparator: Placebo
  3 Capsules of Placebo
  Intervention: Dietary Supplement: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 4, 2018): 48
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2017
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03659994
• Other Study ID Numbers: 1050-003-PRO-10072015
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Do Vitamins Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Do Vitamins Inc.
• Original Study Sponsor: Same as current
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Investigators: Not Provided
• PRS Account: Do Vitamins Inc.
• Verification Date: September 2018