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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

Brief Summary:
Hair loss study in men with self-perceived thinning hair and loss

Condition or disease Intervention/treatment Phase
Hair Loss Hair Thinning Dietary Supplement: Oral Nutraceutical Supplement Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : July 2, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Oral Nutraceutical Supplement Dietary Supplement: Oral Nutraceutical Supplement
Standardized Botanicals. Take 4 capsules by mouth daily with a meal

Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo. Take 4 capsules by mouth daily with a meal




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Shaft Thickness [ Time Frame: Day 90, 180, 270, 360 ]
  2. Hair density [ Time Frame: Day 90, 180, 270, 360 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males only
Accepts Healthy Volunteers:   Yes
Criteria

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.

    -


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): NCT03709563


Locations
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United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
DeNova Research
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Responsible Party: DeNova Research
ClinicalTrials.gov Identifier: NCT03709563    
Other Study ID Numbers: HAIR 2018
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical