Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

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Brief Title

Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Changes in Terminal Hair Count at 26 Weeks Compared to Baseline

Secondary Outcome

 Global Assessment of Improvement from Baseline to 26 and 52 weeks Assessed for Vertex and Frontal Views Separately

Condition

Androgenetic Alopecia

Intervention

HCap Formula

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

33

Start Date

May 2014

Completion Date

May 2015

Primary Completion Date

February 2015

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.
      

Gender

Male

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

David J Friedman, MD, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT02150187

Organization ID

ProHair01


Responsible Party

Sponsor

Study Sponsor

Family Marketing


Study Sponsor

David J Friedman, MD, Principal Investigator, Friedman Skin & Laser Center


Verification Date

July 2017