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Oral Nutraceutical Supplement With Standardized Botanicals in Males With Self-Perceived Thinning Hair and Loss

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: NCT03709563
Recruitment Status : Active, not recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
DeNova Research

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 17, 2018
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date July 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
Hair counts [ Time Frame: Day 90, 180, 270, 360 ]
The change in vellus and terminal hair counts / average number of hairs (N/cm2) within 2 ROIs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
  • Shaft Thickness [ Time Frame: Day 90, 180, 270, 360 ]
  • Hair density [ Time Frame: Day 90, 180, 270, 360 ]
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 Oral Nutraceutical Supplement With Standardized Botanicals in Males With Self-Perceived Thinning Hair and Loss
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of an Oral Nutraceutical Supplement With Standardized Botanicals in Males With Self-Perceived Thinning Hair and Loss
Brief Summary Hair loss study in men with self-perceived thinning hair and loss
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hair Loss
  • Hair Thinning
Intervention  ICMJE
  • Dietary Supplement: Oral Nutraceutical Supplement
    Standardized Botanicals. Take 4 capsules by mouth daily with a meal
  • Dietary Supplement: Placebo
    Placebo. Take 4 capsules by mouth daily with a meal
Study Arms  ICMJE
  • Active Comparator: Oral Nutraceutical Supplement
    Intervention: Dietary Supplement: Oral Nutraceutical Supplement
  • 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 15, 2018)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date July 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males between 21-45 years of age, inclusive
  2. Have self-reported thinning or hair loss for more than 3 months prior to screening
  3. Clinically confirmed to have hair loss or thinning by the investigator via physical exam, including subjects with male pattern hair loss with frontal and vertex patterns II, IIIv or IV using the Norwood Hamilton Hair Loss Scale (NHS).
  4. In good general health, as determined by the Investigator
  5. Willing and able to attend all study visits
  6. Willing to maintain the same hair style as at the Screening Visit for the duration of the study.
  7. 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)
  8. Be willing and able to cooperate with the requirements of the study.
  9. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board.
  10. Be able to complete and understand the various rating instruments in English.

    -

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. 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.
  4. History of surgical correction of hair loss on the scalp (i.e. Hair transplant).
  5. Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 6 months prior to the Baseline Visit.
  6. Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, progesterone, and bicalutamide) within 3 months prior to the Baseline Visit.
  7. History of burning, flaking, itching, and stinging of the scalp.
  8. History of malignancy (except cutaneous squamous cell carcinoma and basal cell carcinoma) or currently undergoing chemotherapy or radiation treatments.
  9. 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.
  10. A known history of depression or bipolar disease or any other condition that may impact the subject's participation in the opinion of the investigator.
  11. Recent utilization of low level lasers for hair growth.
  12. Any condition that the Investigator thinks may put the Subject at risk or interfere with their participation in the study.
  13. Known history or recent blood work indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage >20 cigarettes/day.
  14. Use of any medications that are known to potentially cause hair loss or affect hair growth, as determined by the Investigator.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Males only
Ages  ICMJE 21 Years to 45 Years   (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 NCT03709563
Other Study ID Numbers  ICMJE HAIR 2018
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
Plan to Share IPD: No
Responsible Party DeNova Research
Study Sponsor  ICMJE DeNova Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DeNova Research
Verification Date October 2019

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