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| Name | Class |
|---|---|
| Complife Italia Srl | INDUSTRY |
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The study is aimed to assess the efficacy of a food supplement in reducing hair loss and accelerating the physiological growth in terms of elongation in female subjects showing acute telogen effluvium. Moreover, the efficacy of the product in increasing hair elasticity, thickness and brightness will be assess.
In order to reach this goal a randomized, double-blind, placebo controlled, parallel group (2 arms), clinical trial is carried out on 66 healthy female subjects aged between 18 and 52 years old, showing acute telogen effluvium will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active product | Active Comparator | Hard shell capsule containing 280 mg of active compound. |
|
| Placebo | Placebo Comparator | Hard shell capsule containing maltodextrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast | Dietary Supplement | Hard shell capsule containing 280mg of the oral formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anagen hair density | Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan) | after 84 days of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hair brightness | 8° gloss value (average value of 5 measures) using spectrophotometer/colorimeter CM 700D (Konica-Minolta). | after 42 and 84 days of supplementation |
| Change in hair elasticity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria Roveda, MD, PhD | Complife Italia srl Via Mons. Angelini, 21 27028 San Martino Siccomario (PV) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complife Italia srl | San Martino Siccomario | 27028 | Italy |
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| Placebo | Dietary Supplement | Hard shell capsule containing maltodextrine |
|
using a dynamometer (Tensolab 2512A, Mesdan Lab)
| after 42 and 84 days of supplementation |
| Change in hair volume | Using a 7-point scale administred by a dermatologist | after 42 and 84 days of supplementation |
| Change in hair loss | Number of extracted hairs using a pull test | after 42 and 84 days of supplementation |
| Change in Total Hair Density | Number of total hairs per cm² using phototricogram (TrichoScan) | after 42 and 84 days of supplementation |
| Change in Telogene Hair Density | Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan) | after 42 and 84 days of supplementation |
| Change in Anagen hair density | Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan) | after 42 days of supplementation |