ClinicalTrials.gg
CompletedNCT03052413Updated Jan 2, 2019

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

An interventional study of Nutrafol and placebo in Hair Loss, sponsored by Sadick Research Group. Completed at 2 sites in United States. Open to female participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-01-02.

Sponsored by Sadick Research Group · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Hair Loss

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Keywords

  • thinning hair
  • female pattern hair loss
03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's enrollment of 21 is below the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Sadick Research Group is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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

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 who are not using an approved method of (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as (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 (except scc and bcc skin cancers) or undergoing chemotherapy or radiation treatments.
  10. A known history of 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 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Active comparator
    Active

    Dietary Supplement: Nutrafol

  • Placebo comparator
    Placebo

    Dietary Supplement: placebo

Interventions

  • Dietary supplementNutrafol

    Eligible subjects will receive Nutrafol® to take daily for 180 days

  • Dietary supplementplacebo

    Eligible subjects will receive Placebo to take daily for 180 days

06

What researchers measure

Primary outcomes

  1. change in hair density

    change in hair density over the course of the study assessed by hair count

    Time frame: 180 days

07

Study locations

2 sites
  • New Jersey Plastic Surgery
    Montclair, New Jersey 07042, United States
  • Sadick Research Group
    New York, New York 10075, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2016 to primary completion in Nov 2017, 11 months.

Of 85 non-industry interventional studies with no phase under Alopecia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's 11 months is below that.

Counting every sponsor, half of 146 studies reached it within 12 months; a quarter within 6 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2017
First posted
Feb 14, 2017
StartActual
Dec 2016
Primary completionActual
Nov 10, 2017
CompletionActual
Nov 10, 2017
Last update
Jan 2, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03052413
Lead sponsor
Sadick Research Group
Responsible party
Sponsor
First posted
Feb 14, 2017
Start date
Dec 2016
Primary completion
Nov 10, 2017
Completion
Nov 10, 2017
Last update
Jan 2, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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