Hair LossNCT03052413
Study to Evaluate a Nutraceutical Supplement for Treatment of Hair Loss and Thinning in Females
A study testing Nutrafol in people with Hair Loss, run by Sadick Research Group at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 55 years, women only
- Conditions the study is for
- Hair Loss
- What is being tested?
- Nutrafol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 10 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females between 21 - 55 years of age, inclusive
- Skin type I-IV
- Have self-reported thinning or hair loss for more than 6 months prior to screening
- 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)
- In good general health, as determined by the Investigator
- Willing and able to attend all study visits
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- 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.
- 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)
- Willing to have their hair clipped and scalp tattoo
- 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.
- Be willing and able to cooperate with the requirements of the study.
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board.
- Be able to complete and understand the various rating instruments in English.
- Sponsor approved global image assessment of degree of thinning / hair loss
Who cannot join
- Clinical diagnosis of alopecia areata or scarring forms of alopecia
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- 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.
- 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.
- History of surgical correction of hair loss on the scalp/ Hair transplants.
- 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.
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- Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 30 days prior to the Baseline Visit.
- No history of burning, flaking, itching, and stinging of the scalp.
- History of malignancy (except scc and bcc skin cancers) or undergoing chemotherapy or radiation treatments.
- 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.
- A known history of depression or bi-polar disease or any other condition that may impact the subject's participation.
- Subjects taking vitamin E supplements can participate, provided medication is interrupted 14 days before baseline visit.
- Recent utilization of low level lasers.
- Has any condition that the treating investigator or PI thinks may put the Subject at risk or interfere with their participation in the study.
- Is involved in any injury litigation claims
- 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.
- Use of any medications that are known to potentially cause hair loss or affect hair growth, as determined by PI.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New Jersey Plastic Surgery
Montclair, New Jersey, 07042
Sadick Research Group
New York, New York, 10075
About this study
Official title: Study to Evaluate Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals for Treatment of Hair Loss and Thinning in Females
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.
- Conditions
- Hair Loss
- Being tested
- Nutrafol, placebo
- Keywords
- thinning hair, female pattern hair loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutrafolDietary supplement
Eligible subjects will receive Nutrafol® to take daily for 180 days
placeboDietary supplement
Eligible subjects will receive Placebo to take daily for 180 days
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Not described Receives: Dietary Supplement: Nutrafol |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in hair density
change in hair density over the course of the study assessed by hair count
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startDec 2016
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadick Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052413
- Sponsor's protocol ID
- SRG-Nutra-01
- Status last verified
- Dec 2018
- First submitted
- 10 Feb 2017
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals for Treatment of Hair Loss and Thinning in Females
- ClinicalTrials.gov ID
- NCT03052413
- Acronym / sponsor ID
- SRG-Nutra-01
- Conditions
- Hair Loss
- Keywords
- thinning hair, female pattern hair loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sadick Research GroupUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Nutrafol |
| Placebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Females between 21 - 55 years of age, inclusive
- Skin type I-IV
- Have self-reported thinning or hair loss for more than 6 months prior to screening
- 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)
- In good general health, as determined by the Investigator
Key exclusion criteria (17 listed)
- Clinical diagnosis of alopecia areata or scarring forms of alopecia
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- 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.
- 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.
- History of surgical correction of hair loss on the scalp/ Hair transplants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutrafolEligible subjects will receive Nutrafol® to take daily for 180 days | Dietary supplement | Active |
| placeboEligible subjects will receive Placebo to take daily for 180 days | Dietary supplement | Placebo |
Primary outcome
change in hair density
Time frame: 180 days
change in hair density over the course of the study assessed by hair count
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrafol in people with Hair Loss, run by Sadick Research Group at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in hair density (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.