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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCap Formula | Experimental | Pill of HCap Formula every other day for 6 month during the treatment phase; Follow up phase: nothing. |
|
| Placebo | Placebo Comparator | Same as treatment with placebo pills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCap Formula | Dietary Supplement | Pill should be taken every other day during the treatment phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| David J Friedman, MD | Friedman Skin & Laser Center | Principal Investigator |
| Lilach Gavish, PhD | Friedman Skin & Laser Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr David Friedman Laser & Skin Center | Jerusalem | 9644035 | Israel |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo | Dietary Supplement | Similar pills without active ingredients |
|
| Baseline, 26 weeks, 52 weeks |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |