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Trial record 30 of 50 for:    Recruiting, Not yet recruiting, Available Studies | "Alopecia"

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

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ClinicalTrials.gov Identifier: NCT03052413
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sadick Research Group

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.

Condition or disease Intervention/treatment Phase
Hair Loss Dietary Supplement: Nutrafol Dietary Supplement: placebo Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Evaluate Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals for Treatment of Hair Loss and Thinning in Females
Actual Study Start Date : December 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Dietary Supplement: Nutrafol
Eligible subjects will receive Nutrafol® to take daily for 180 days

Placebo Comparator: Placebo Dietary Supplement: placebo
Eligible subjects will receive Placebo to take daily for 180 days




Primary Outcome Measures :
  1. change in hair density [ Time Frame: 180 days ]
    change in hair density over the course of the study assessed by hair count



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052413


Contacts
Contact: Krista Bohnert, BS 2127727242 kbohnert@sadickdermatology.com
Contact: Neil Sadick, MD 2127727242 nssderm@sadickdermatology.com

Locations
United States, New Jersey
New Jersey Plastic Surgery Recruiting
Montclair, New Jersey, United States, 07042
Contact: Simone Francis    973-509-2000    SFRANCIS@NJPSMD.COM   
Principal Investigator: Barry DiBernardo, MD         
United States, New York
Sadick Research Group Recruiting
New York, New York, United States, 10075
Contact: Krista Bohnert    212-772-7242    kbohnert@sadickdermatology.com   
Principal Investigator: Neil Sadick, MS         
Sponsors and Collaborators
Sadick Research Group

Responsible Party: Sadick Research Group
ClinicalTrials.gov Identifier: NCT03052413     History of Changes
Other Study ID Numbers: SRG-Nutra-01
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sadick Research Group:
thinning hair
female pattern hair loss

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical