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Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

Primary Purpose

Androgenetic Alopecia

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
HCap Formula
Placebo
Sponsored by
Family Marketing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Androgenetic Alopecia, Male, Baldness, hair loss pattern

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Dr David Friedman Laser & Skin Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HCap Formula

Placebo

Arm Description

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

Same as treatment with placebo pills

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2014
Last Updated
July 14, 2017
Sponsor
Family Marketing
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1. Study Identification

Unique Protocol Identification Number
NCT02150187
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Family Marketing

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Androgenetic Alopecia, Male, Baldness, hair loss pattern

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCap Formula
Arm Type
Experimental
Arm Description
Pill of HCap Formula every other day for 6 month during the treatment phase; Follow up phase: nothing.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Same as treatment with placebo pills
Intervention Type
Dietary Supplement
Intervention Name(s)
HCap Formula
Intervention Description
Pill should be taken every other day during the treatment phase.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Similar pills without active ingredients
Primary Outcome Measure Information:
Title
Changes in Terminal Hair Count at 26 Weeks Compared to Baseline
Description
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.
Time Frame
Baseline, 26 Weeks
Secondary Outcome Measure Information:
Title
Global Assessment of Improvement from Baseline to 26 and 52 weeks Assessed for Vertex and Frontal Views Separately
Description
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
Time Frame
Baseline, 26 weeks, 52 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Friedman, MD
Organizational Affiliation
Friedman Skin & Laser Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lilach Gavish, PhD
Organizational Affiliation
Friedman Skin & Laser Center
Official's Role
Study Director
Facility Information:
Facility Name
Dr David Friedman Laser & Skin Center
City
Jerusalem
ZIP/Postal Code
9644035
Country
Israel

12. IPD Sharing Statement

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Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

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