Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

Family Marketing

Status and phase

Completed

Phase 2

Conditions

Androgenetic Alopecia

Treatments

Dietary Supplement: HCap Formula

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02150187

ProHair01

Details and patient eligibility

About

HCap Formula is composed of medicinal plants, vitamins and minerals. The purpose of this study is to evaluate the efficacy of HCap Formula, a nutrition supplement for promoting hair growth in men with tendencies for hair loss.

Full description

This study consists of a treatment phase (6 months) and a follow-up phase (6 month ). Eligible subjects will be randomly assigned to receive treatment with the study medication or placebo. Subjects will visit the clinic at 3, 6, and 12 months after treatment start for safety and efficacy evaluations.

HCap Formula or placebo tablets will be taken orally every other day during 6 months.

Enrollment

33 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males between 18-40 years of age.
No abnormality in blood tests analysis
Present with mild to moderate androgenic alopecia (AGA) graded IIv, IIIv, IV or V according to the Hamilton-Norwood classification
Willingness to use the same shampoo, refrain from change in hair style, and refrain from hair dyeing during the study.
Willingness to refrain from any therapy affecting hair during the study
Willingness to have photographs of the treated area taken.
Willingness to follow the treatment schedule and post treatment follow-up.
Willingness not participate on other studies during the study course

Exclusion criteria

General

Having a known allergy to any of the ingredients in the test products;
Participation in a study of another device or drug within one month prior to enrollment or during the study.

Hair treatments/ scalp condition
Undergone hair transplant surgery, scalp reduction surgery
Having hair weave or tattooing of the alopecic area.
Other hair loss disorders, such as alopecia areata, scarring alopecia.
Suffering from any active dermatological condition in the treated area such as scalp atrophy, which in the opinion of the investigator might interfere with clinical evaluation.

Medications

Use of the following medications within the past 6 months:
Prescription or over-the-counter systemic or topical treatment specific for androgenic alopecia (such as minoxidil, finasteride, dutasteride).
5α-reductase inhibitors for prostate conditions (e.g. benign prostate hyperplasia, prostate cancer) and hormone replacement therapy for transgenders
Medications with anti-androgenic properties (cyproterone, spironolactone, ketoconazole, flutamide, progesterone, and bicalutamide)
Medications that can potentially cause hypertrichosis (e.g. cyclosporine, diazoxide, phenothiazines, zidovudine, tamoxifen, carpronium chloride),
Medications that can potentially cause alopecia such as oral glucocorticoids, lithium, phenothiazines, tamoxifen.

Use of the following medications within the past 3 months:
Botanicals/nutraceuticals for hair growth
Steroids - systemic steroids for more than 14 days (e.g. corticosteroids, anabolic steroids) or topical steroids on the area of hair loss.

Other medical conditions
Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), uncontrolled hypertension, symptomatic hypotension, hyper/hypo thyroidism, or pertinent neurological disorders.
Suffering from serious medical condition that could adversely affect hair loss such as immunosuppression/immune deficiency disorders (including HIV), history of cancer or having/undergoing any form of treatment for active cancer, connective tissue disorder, inflammatory bowel disease
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.