Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

Evaluation of the Efficacy of Hcap Formula Nutrition Supplement for Treatment of Men With Androgenic Alopecia: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Dietary supplement: HCap Formula; Dietary supplement: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 9644035
    • Dr David Friedman Laser & Skin Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

General

1. Having a known allergy to any of the ingredients in the test products;

2. Participation in a study of another device or drug within one month prior to enrollment or during the study.

   Hair treatments/ scalp condition

3. Undergone hair transplant surgery, scalp reduction surgery
4. Having hair weave or tattooing of the alopecic area.
5. Other hair loss disorders, such as alopecia areata, scarring alopecia.

6. 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:

7. Prescription or over-the-counter systemic or topical treatment specific for androgenic alopecia (such as minoxidil, finasteride, dutasteride).
8. 5α-reductase inhibitors for prostate conditions (e.g. benign prostate hyperplasia, prostate cancer) and hormone replacement therapy for transgenders
9. Medications with anti-androgenic properties (cyproterone, spironolactone, ketoconazole, flutamide, progesterone, and bicalutamide)
10. Medications that can potentially cause hypertrichosis (e.g. cyclosporine, diazoxide, phenothiazines, zidovudine, tamoxifen, carpronium chloride),

11. Medications that can potentially cause alopecia such as oral glucocorticoids, lithium, phenothiazines, tamoxifen.

    Use of the following medications within the past 3 months:

12. Botanicals/nutraceuticals for hair growth

13. 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

14. 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.
15. 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
16. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HCap Formula; Pill of HCap Formula every other day for 6 month during the treatment phase; Follow up phase: nothing.	Dietary supplement: HCap Formula; Pill should be taken every other day during the treatment phase.
PLACEBO_COMPARATOR: Placebo; Same as treatment with placebo pills	Dietary supplement: Placebo; Similar pills without active ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Terminal Hair Count at 26 Weeks Compared to Baseline	The primary outcome will be change in the terminal hair count from baseline to 26 Weeks within a 3 cm diameter circle based on macro-photographs of the same area. The treatment group will be compared to the control.	Baseline, 26 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Assessment of Improvement from Baseline to 26 and 52 weeks Assessed for Vertex and Frontal Views Separately	Assessment of improvement using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). This assessment will be performed by comparing the global photographs obtained at Baseline with those subsequently obtained at baseline, 26, and 52 weeks. This assessment will be carried out separately on the global photography of the vertex and frontal views	Baseline, 26 weeks, 52 weeks

Collaborators and Investigators

• Sponsor: Family Marketing

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (ESTIMATE): May 29, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 14, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Male; Baldness; Androgenetic Alopecia; hair loss pattern
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: ProHair01