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

NCT03659994 | Completed

• 1 other identifier: 1050-003-PRO-10072015
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine dose-dependent effects of Vitabeard on various parameters of facial hair growth.

Conditions

Healthy

Keywords

Facial Hair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Facial hair density

  33 days

• Facial hair strand thickness

  33 days

Study Arms (4)

Vitabeard High Dose

EXPERIMENTAL

3 capsules of multivitamin Vitabeard

Dietary Supplement: Multivitamin

Vitabeard Mid-Dose

EXPERIMENTAL

2 Capsules of multivitamin Vitabeard, 1 Capsule of Placebo

Dietary Supplement: Multivitamin

Vitabeard Low-Dose

EXPERIMENTAL

1 Capsule of multivitamin Vitabeard, 2 Capsules of Placebo

Dietary Supplement: Multivitamin

Placebo

PLACEBO COMPARATOR

3 Capsules of Placebo

Dietary Supplement: Placebo

Interventions

Multivitamin DIETARY_SUPPLEMENT

Vitabeard

Vitabeard High Dose; Vitabeard Low-Dose; Vitabeard Mid-Dose

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Do Vitamins Inc.: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Nutrasource

Guelph, Ontario, N1G0B4, Canada

Location

MeSH Terms

Interventions

Geritol

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)