Clinical trial NCT02150187: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Androgenetic Alopecia
Keywords: Androgenetic Alopecia
Male
Baldness
hair loss pattern
Lead sponsor: Family Marketing
Sponsor class: INDUSTRY
First posted: 2014-05-29
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in Terminal Hair Count at 26 Weeks Compared to Baseline
timeFrame: Baseline, 26 Weeks
Secondary outcomes:
measure: Global Assessment of Improvement from Baseline to 26 and 52 weeks Assessed for Vertex and Frontal Views Separately
timeFrame: Baseline, 26 weeks, 52 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Dr David Friedman Laser & Skin Center
Study officials:
affiliation: Friedman Skin & Laser Center
name: David J Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Friedman Skin & Laser Center
name: Lilach Gavish, PhD
role: STUDY_DIRECTOR
References: