A Randomized, Double-blind, Clinical Trial to Compare the Effects of VitaBeard® on Facial Hair Growth in Healthy Adult Men
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Do Vitamins Inc.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Rate of Facial Hair Growth
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
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
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Facial hair density(33 days)
- Facial hair strand thickness(33 days)