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| Name | Class |
|---|---|
| Complife Italia Srl | INDUSTRY |
| University of Pavia | OTHER |
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According to the American Hair Loss Association, by the age of 35, two-thirds of American men will have some degree of appreciable hair loss, and by the age of 50, approximately 50 to 85% of men will have significant hair thinning.
Hair is an essential aspect of human appearance and can have a significant impact on a person's self-esteem, mood and quality of life. Unfortunately, current treatment options can be costly, tedious or painful. They are also associated with numerous side effects.
Here, the investigators aimed at evaluating the effect of a new food supplement on hair condition in young men suffering from hair loss. A second goal was to determine tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alline proMEN | Experimental | The qualitative and quantitative formula is as follows: 500 mg Keratin, 225 mg Inactive dried yeast rich in vitamin (containing 200 mg Saccharomyces cerevisiae 100% inactivated, 11.218.4 mg Vitamin B3, 6.8-7.2 mg Vitamin B5, 1.6-1.8 mg Vitamin B6, 1.6-1.8 mg Vitamin B2, 1.6 -1.8 mg Vitamin B1, 0.2-0.4 mg Vitamin B9, 0.2 mg Vitamin B8, 5.6 μg Vitamin B12), 150 mg Venus hair fern extract, 117.6 mg Iron gluconate (containing 14.7 mg Iron), 84.2 mg Sodium ascorbate coated, 76.8 mg Zinc gluconate (11 mg Zinc) 24 mg Beta carotene 20%, 14.8 mg Vitamin E, 256.3 mg Acacia gum, 100 mg Microcrystalline cellulose, 11.3 mg Magnesium stearate, 78 mg White coating (containing: 23.4-39 mg Hydroxypropylmethylcellulose (E464), 15.6-23.4 mg Calcium sulfate anhydrous (E516), 15.6-23.4 mg Magnesium carbonate, light (E504), 7.8-15.6 mg Hydroxypropylcellulose (E463), 3.9-11.7 mg Stearic acid (E570)). |
|
| Placebo | Placebo Comparator | 1095 mg Microcrystalline cellulose, 5 mg Magnesium stearate, 55 mg White coating (containing: 16.5-27.5 mg Hydroxypropylmethylcellulose (E464), 11.0-16.5 mg Calcium sulfate anhydrous (E516), 11.0-16.5 mg Magnesium carbonate, light (E504), 5.5-11.0 mg Hydroxypropylcellulose (E463), 2.8-8.2 mg Stearic acid (E570). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alline proMEN | Dietary Supplement | 1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in the number of hair in anagen and telogen phases at day 30 and 86. | The total number of hair (hair density) and the number of hair in the anagen phase will be determined by phototricogram. Briefly, all hairs in a 2 sq cm area are trimmed 1 mm from the skin surface. The hair is dyed and a baseline photograph is taken. After 48h, the same region is photographed again. By comparing with the baseline picture, one can observe as to which hair fibers have grown (follicles in anagen) and which have not (follicles in telogen) and the density of the hair (the number of hairs in the photograph). Anagen hair will be manually counted comparing side by side the photographs taken at each checkpoint and 48 hours after. Telogen hair will be calculated as the difference between the total hair number and the anagen hair number. | Day 0, Day 30, Day 86 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in hair radiance (au) at day 28 and day 84 | Hair radiance will be measured by spectrophotometry. | Day 0, Day 28, Day 84 |
| Changes from baseline in hair elongation (%) at day 28 and day 84 |
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Inclusion Criteria:
Criteria related to population
Criteria related to subject's health
Criteria related to hair loss disorders
Exclusion Criteria:
Criteria related to the population
Criteria related to subject's health
Criteria related to hair loss disorders
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| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Nobile, PhD | Complife Italia Srl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complife Italia S.r.l | Pavia | 27028 | Italy |
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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 | 1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months |
|
Hair elongation (hair elasticity) will be evaluated by means of dynamometer reading. The dynamometer reading will be done on a single hair fiber. In total 10 hair fibers/participant will be measured.
| Day 0, Day 28, Day 84 |
| Changes from baseline in hair breakage force (cN) at day 28 and day 84 | The force at which the hair breaks (breakage force) will be evaluated by means of dynamometer reading. The dynamometer reading will be done on a single hair fiber. In total 10 hair fibers will be measured. | Day 0, Day 28, Day 84 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |