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

NCT03709563 | Terminated

• 1 other identifier: HAIR 2018
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hair Loss; Hair Thinning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Shaft Thickness

  Day 90, 180, 270, 360

• Hair density

  Day 90, 180, 270, 360

Study Arms (2)

Oral Nutraceutical Supplement

ACTIVE COMPARATOR

Dietary Supplement: Oral Nutraceutical Supplement

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Oral Nutraceutical Supplement DIETARY_SUPPLEMENT

Standardized Botanicals. Take 4 capsules by mouth daily with a meal

Oral Nutraceutical Supplement

Placebo DIETARY_SUPPLEMENT

Placebo. Take 4 capsules by mouth daily with a meal

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: Males only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males between 21-45 years of age, inclusive
• Have self-reported thinning or hair loss for more than 3 months prior to screening
• 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).
• In good general health, as determined by the Investigator
• Willing and able to attend all study visits
• Willing to maintain the same hair style as at the Screening Visit for the duration of the study.
• 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)
• 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.

You may not qualify if:

• Clinical diagnosis of alopecia areata or scarring forms of alopecia
• Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
• 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 (i.e. Hair transplant).
• 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.
• Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, progesterone, and bicalutamide) within 3 months prior to the Baseline Visit.
• History of burning, flaking, itching, and stinging of the scalp.
• History of malignancy (except cutaneous squamous cell carcinoma and basal cell carcinoma) or currently 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 bipolar disease or any other condition that may impact the subject's participation in the opinion of the investigator.
• Recent utilization of low level lasers for hair growth.
• Any condition that the Investigator thinks may put the Subject at risk or interfere with their participation in the study.
• 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.
• Use of any medications that are known to potentially cause hair loss or affect hair growth, as determined by the Investigator.

Sponsors & Collaborators

• DeNova Research: lead

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: October 15, 2018
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)