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

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

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

Study Overview

• Status: Terminated
• Conditions: Hair Loss; Hair Thinning
• Intervention / Treatment: Dietary supplement: Oral Nutraceutical Supplement; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo. Take 4 capsules by mouth daily with a meal
Active Comparator: Oral Nutraceutical Supplement	Dietary supplement: Oral Nutraceutical Supplement; Standardized Botanicals. Take 4 capsules by mouth daily with a meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair counts	The change in vellus and terminal hair counts / average number of hairs (N/cm2) within 2 ROIs	Day 90, 180, 270, 360

Secondary Outcome Measures

Outcome Measure	Time Frame
Shaft Thickness	Day 90, 180, 270, 360
Hair density	Day 90, 180, 270, 360

Collaborators and Investigators

• Sponsor: DeNova Research

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hair Diseases; Alopecia; Alopecia Areata; Hypotrichosis
• Other Study ID Numbers: HAIR 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No