Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

NCT02150187 | Completed Phase 2

• 1 other identifier: ProHair01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Keywords

Androgenetic Alopecia; Male; Baldness; hair loss pattern

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline, 26 weeks, 52 weeks

Study Arms (2)

HCap Formula

EXPERIMENTAL

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

Dietary Supplement: HCap Formula

Placebo

PLACEBO COMPARATOR

Same as treatment with placebo pills

Dietary Supplement: Placebo

Interventions

HCap Formula DIETARY_SUPPLEMENT

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

HCap Formula

Placebo DIETARY_SUPPLEMENT

Similar pills without active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).
• α-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.

Sponsors & Collaborators

• Family Marketing: lead

Study Sites (1)

Dr David Friedman Laser & Skin Center

Jerusalem, 9644035, Israel

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• David J Friedman, MD

  Friedman Skin & Laser Center

  PRINCIPAL INVESTIGATOR

• Lilach Gavish, PhD

  Friedman Skin & Laser Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 29, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

IL (1)