Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

NCT ID: NCT02150187

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-05-31

Brief Summary

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.

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.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HCap Formula

Pill of HCap Formula every other day for 6 month during the treatment phase; Follow up phase: nothing.

Group Type: EXPERIMENTAL

HCap Formula

Intervention Type: DIETARY_SUPPLEMENT

Pill should be taken every other day during the treatment phase.

Placebo

Same as treatment with placebo pills

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Similar pills without active ingredients

Interventions

HCap Formula

Pill should be taken every other day during the treatment phase.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Similar pills without active ingredients

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Family Marketing

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Friedman Skin & Laser Center

Lilach Gavish, PhD

Role: STUDY_DIRECTOR

Friedman Skin & Laser Center

Locations

Dr David Friedman Laser & Skin Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

ProHair01

Identifier Type: -

Identifier Source: org_study_id