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Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

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ClinicalTrials.gov Identifier: NCT02150187
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Family Marketing

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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Dietary Supplement: HCap Formula Dietary Supplement: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HCap Formula
Pill of HCap Formula every other day for 6 month during the treatment phase; Follow up phase: nothing.
Dietary Supplement: HCap Formula
Pill should be taken every other day during the treatment phase.

Placebo Comparator: Placebo
Same as treatment with placebo pills
Dietary Supplement: Placebo
Similar pills without active ingredients




Primary Outcome Measures :
  1. Changes in Terminal Hair Count at 26 Weeks Compared to Baseline [ Time Frame: Baseline, 26 Weeks ]
    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 :
  1. Global Assessment of Improvement from Baseline to 26 and 52 weeks Assessed for Vertex and Frontal Views Separately [ Time Frame: Baseline, 26 weeks, 52 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150187


Locations
Israel
Dr David Friedman Laser & Skin Center
Jerusalem, Israel, 9644035
Sponsors and Collaborators
Family Marketing
Investigators
Principal Investigator: David J Friedman, MD Friedman Skin & Laser Center
Study Director: Lilach Gavish, PhD Friedman Skin & Laser Center

Responsible Party: Family Marketing
ClinicalTrials.gov Identifier: NCT02150187     History of Changes
Other Study ID Numbers: ProHair01
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

Keywords provided by Family Marketing:
Androgenetic Alopecia
Male
Baldness
hair loss pattern

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical