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Study to Evaluate a Nutraceutical Supplement for Treatment of Hair Loss and Thinning in Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03052413
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : January 2, 2019
Information provided by (Responsible Party):
Sadick Research Group

Tracking Information
First Submitted Date  ICMJE February 10, 2017
First Posted Date  ICMJE February 14, 2017
Last Update Posted Date January 2, 2019
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date November 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
change in hair density [ Time Frame: 180 days ]
change in hair density over the course of the study assessed by hair count
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study to Evaluate a Nutraceutical Supplement for Treatment of Hair Loss and Thinning in Females
Official Title  ICMJE Study to Evaluate Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals for Treatment of Hair Loss and Thinning in Females
Brief Summary The objective of this study is to assess the safety and effectiveness of a nutraceutical supplement for the treatment of hair loss and thinning in females over the course of six months of continuous daily use.
Detailed Description This is a randomized, double-blind, placebo-controlled, study in adult female subjects with mild to moderate hair loss. Following an up to 35-day screening period to determine eligibility, subjects will be randomly assigned into one of the following treatment arms: Nutrafol® vs. Placebo. Nutrafol® or Placebo will randomly assigned be administered daily to the subjects for 6 months starting on Day 2. The subjects will return to the study site at Day 90 and Day 180 for assessments. Additionally, the subjects will return to the study site approximately 48 hours after Day 0 (Baseline Visit) and D180 in order to assess hair growth rate. Nutrafol® or Placebo will be dispensed by the non-blinded study staff with nonlabeled containers containing the corresponding tablets. Efficacy ratings will be performed by a trained investigator who will not be aware of the subject's treatment randomization in order to preserve double-blinding of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hair Loss
Intervention  ICMJE
  • Dietary Supplement: Nutrafol
    Eligible subjects will receive Nutrafol® to take daily for 180 days
  • Dietary Supplement: placebo
    Eligible subjects will receive Placebo to take daily for 180 days
Study Arms  ICMJE
  • Active Comparator: Active
    Intervention: Dietary Supplement: Nutrafol
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 31, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2017)
Actual Study Completion Date  ICMJE November 10, 2017
Actual Primary Completion Date November 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Females between 21 - 55 years of age, inclusive
  2. Skin type I-IV
  3. Have self-reported thinning or hair loss for more than 6 months prior to screening
  4. Clinically confirmed to have hair loss or thinning by the investigator via physical exam, including subjects with female pattern hair loss with Savin Classification score of I2-II1 as determined by the investigator (through medical history, physical exam and /or strong family history of hair loss as defined by 2 or more relatives known to have a similar Savin pattern of loss without diagnosed disease)
  5. In good general health, as determined by the Investigator
  6. Willing and able to attend all study visits
  7. Willing to maintain the same hair style as at the Screening Visit for the duration of the study. If coloring hair, willing to color it with the same frequency of usage as in the past, making sure not to color within 3 weeks of an in-office appointment.
  8. Willing to use a mild non-medicated shampoo and conditioner for the duration of the study (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth)
  9. Willing to have their hair clipped and scalp tattoo
  10. Have a negative urine pregnancy test at screening and be using, and continue to use for the duration of the study, an effective contraception method (ie, abstinence, barrier control, intrauterine device [IUD], or hormonal [estrogen/progestin] contraceptives) for at least one menstrual cycle prior to study; if using IUD or hormonal contraceptives - then at least 2 years prior to screening, the initiation of which should not have been associated with initiation of hair loss/thinning.
  11. Be willing and able to cooperate with the requirements of the study.
  12. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board.
  13. Be able to complete and understand the various rating instruments in English.
  14. Sponsor approved global image assessment of degree of thinning / hair loss

Exclusion Criteria:

  1. Clinical diagnosis of alopecia areata or scarring forms of alopecia
  2. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
  3. Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy, or Subjects of childbearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as postmenopausal (absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy.
  4. Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations.
  5. History of surgical correction of hair loss on the scalp/ Hair transplants.
  6. Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 30 days prior to the Baseline Visit.
  7. Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 30 days prior to the Baseline Visit.
  8. No history of burning, flaking, itching, and stinging of the scalp.
  9. History of malignancy (except scc and bcc skin cancers) or undergoing chemotherapy or radiation treatments.
  10. A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that in the opinion of the investigator may interfere with the study treatment.
  11. A known history of depression or bi-polar disease or any other condition that may impact the subject's participation.
  12. Subjects taking vitamin E supplements can participate, provided medication is interrupted 14 days before baseline visit.
  13. Recent utilization of low level lasers.
  14. Has any condition that the treating investigator or PI thinks may put the Subject at risk or interfere with their participation in the study.
  15. Is involved in any injury litigation claims
  16. Known history or recent bloodwork indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage >20 cigarettes/day.
  17. Use of any medications that are known to potentially cause hair loss or affect hair growth, as determined by PI.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT03052413
Other Study ID Numbers  ICMJE SRG-Nutra-01
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  ICMJE Not Provided
Current Responsible Party Sadick Research Group
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sadick Research Group
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sadick Research Group
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP