Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

Androgenetic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150187
• Other study ID #: ProHair01
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2014
• Last updated: July 14, 2017
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2017
• Source: Family Marketing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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. 5a-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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Dietary Supplement:
• HCap Formula
Pill should be taken every other day during the treatment phase.
• Placebo
Similar pills without active ingredients

Locations

Country	Name	City	State
Israel	Dr David Friedman Laser & Skin Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Family Marketing

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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