Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Women With Thinning Hair
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ClinicalTrials.gov Identifier: NCT03206567 |
Recruitment Status :
Completed
First Posted : July 2, 2017
Last Update Posted : August 7, 2019
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Tracking Information | |||||||
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First Submitted Date ICMJE | June 29, 2017 | ||||||
First Posted Date ICMJE | July 2, 2017 | ||||||
Last Update Posted Date | August 7, 2019 | ||||||
Actual Study Start Date ICMJE | May 4, 2017 | ||||||
Actual Primary Completion Date | December 10, 2017 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Women With Thinning Hair | ||||||
Official Title ICMJE | A 6-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Ability and Safety of a Nutraceutical Supplement With Standardized Botanicals to Promote Hair Growth in Women With Self-Perceived Thinning Hair | ||||||
Brief Summary | NUTRAFOL® is a novel nutraceutical supplement, scientifically formulated to specifically target the multiple underlying causes of hair loss and thinning in women. It does not contain hormones, drugs, or industry by-products. The purpose of this clinical research study is to evaluate the safety, efficacy and physiological effects of NUTRAFOL® supplement compared to placebo in forty (40) female subjects, ages 21-65 years of age with self-perceived thinning hair over the course of six months of continued use. |
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Detailed Description | NUTRAFOL's Synergen Complex® is a patent-pending formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some patented ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, USPlus Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, Bioperine (piperine), Cynatine HNS (solubilized keratin), and Capsimax (capsaicin), all of which are standardized and clinically tested. Ingestion of NUTRAFOL® supplement over a six (6) month period will strengthen and promote the growth of hairs in female subjects, ages 21-65 years of age with self-perceived thinning hair when compared to using the placebo tablet. The primary endpoints will be favorable analysis using the Canon Power Shot G16 with 3GEN Dermlite FOTO Pro for macrophotography hair count analysis of terminal and vellus hairs at the three (3) month and six (6) month visits. The secondary endpoints will be favorable improvement in terminal hair diameter measured by the Dino-Lite Digital Microscopic, favorable improvement in the Hair Check device hair bundle measurement for Hair Mass Index (HMI), favorable improvement in the Blinded Physician Global Hair Assessments for hair growth and hair quality, statistically significant positive feedback on the Women's Hair Loss Quality of Life, Self-Assessment and Subject Treatment Satisfaction and Ease of Use questionnaires after six (6) months of NUTRAFOL® supplement or placebo ingestion. See Table of Study Procedures. All patients enrolled must be identifiable throughout the study. The Investigator will maintain a personal list of patient numbers and patient names to enable records to be found at a later date and the list will be stored in a locked cabinet. Subject numbers consist of a 2 digit number from 01 to 40. Patients will be randomized to active or placebo supplements (2:1 ratio, 26 active and 14 placebo) using a randomization table prepared prior to the start of the study by a non-participating staff member at the office of the Investigator. The study blind will not be broken until the end of the study. All test product and placebo will be labeled with subject numbers per the non-participating staff member. Subjects will be assigned a subject number in numerical order as enrolled. Randomization will occur by assignment to either NUTRAFOL® supplement or placebo with 2:1 ratio (26 active and 14 placebo). Subjects who terminate their study participation for any reason, regardless of whether study medication was used or not, will retain their randomization number. Visit Procedures: Pre-Study Procedures
Visit 1: Baseline, Day 0
Usage Instructions: Take 4 capsules once daily, along with a meal or immediately following (within 5 minuntes) at approximately the same time of the day, every day. Do not take on an empty stomach. If you forgot to take your dose during a meal, do not skip the dose, take it with something fatty, like peanut butter or coconut oil when you remember. Store at room temperature, in a cool dry location. Do not take if broken or seal is compromised. Subjects will be instructed to return all empty bottles and unused test product at Visits 2 and 3. Lifestyle Instructions: Subjects will be instructed to maintain their normal hair care routine. Subjects will be instructed to use the same brand/type of hair care products and maintain the same haircut, color and style for the study duration. Subjects who have color treated hair will also be instructed to have the color treatment performed at the same time interval prior to each visit (ie. If on Visit 1, the color treatment was done one week prior then the color treatment is expected to occur at a similar interval of one week prior to Visits 2 and 3). Subjects will be instructed to come to each visit with clean and dry hair. Subjects will be instructed to use a medically sound form of birth control during the study. Visit 2: Month 3 (90 days) ± 1 week (7 days)
Visit 3: Month 6 (180 days) ± 1 week (7 days)
All primary and secondary parameters will be collected at Visits 1, 2 and 3. Missing data values will be minimized by intensive training of the interviewers in techniques of clarifying answers and checking questionnaires while participants are on-site. When missing values are identified, several approaches such as rescheduled within 24 hours of completion of tests or interviews will be employed to acquire the necessary data. Missing data will be also examined to assess randomness. Descriptive statistics will be obtained for all variables, tests of normality of continuous measures will be made and data will be examined for homogeneity of variance. An appropriate statistical method will be employed to correct for any abnormalities. The comparability of the two treatment groups in baseline demographic and clinical features will be tested with analyses of variance (ANOVAs) for continuous variables and Chi-square analyses for dichotomous variables. Initially, groups will be compared across all three visits for overall interaction effect. For any outcome with significant two-way interaction, group differences from baseline Visit to other two visits will be tested using analyses of variance with repeated measurements. These analyses were performed using the SPSS version 19. All analyses were two-tailed, where applicable, with p-value of 0.05 or less is obtained but other p-values may be evaluated on a case-by-case basis |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Masking Description: Double-blind study Primary Purpose: Treatment
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Condition ICMJE | Hair Thinning | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Ablon G, Kogan S. A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair. J Drugs Dermatol. 2018 May 1;17(5):558-565. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
40 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | March 1, 2018 | ||||||
Actual Primary Completion Date | December 10, 2017 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03206567 | ||||||
Other Study ID Numbers ICMJE | ASIRC-NW-01 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Ablon Skin Institute Research Center | ||||||
Study Sponsor ICMJE | Ablon Skin Institute Research Center | ||||||
Collaborators ICMJE | Nutraceutical Wellness Inc. | ||||||
Investigators ICMJE |
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PRS Account | Ablon Skin Institute Research Center | ||||||
Verification Date | July 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |