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The study is aimed to assess the efficacy of a dietary supplement composed of a Wheat Polar Lipid Complex (WPLC) in reducing hair loss and improving hair aspect.
A double blind, parallel groups, placebo-controlled study is carried out on 60 healthy female subjects aged between 18 and 65 years old with all hair type showing diffuse and temporary hair shedding with a proportion of hair in telogen phase >15%.
The study foresees 84 days of products intake. Evaluations of the parameters under study are performed at baseline, after 56 and 84 days of products consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wheat Polar Lipid Complex | Experimental | Dietary supplement - Wheat Polar Lipid Complex |
|
| Placebo | Placebo Comparator | Dietary supplement - Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wheat Polar Lipid Complex | Dietary Supplement | The study foresees the intake of 2 capsules per day during 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Telogen hair proportion | Phototrichogram | Baseline |
| Telogen hair proportion | Phototrichogram | 56 days |
| Telogen hair proportion | Phototrichogram | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anagen hair proportion | Phototrichogram | Baseline |
| Anagen hair proportion | Phototrichogram | 56 days |
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Inclusion criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ileana De Ponti | Complife Italia Srl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complife Italia srl | Milan | 20024 | Italy |
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| Placebo | Dietary Supplement | The study foresees the intake of 2 capsules per day during 84 days |
|
| Anagen hair proportion | Phototrichogram | 84 days |
| Hair growth | Hair length after shaving | 84 days |
| Hair elasticity | Hair elongation using dynamometer | Baseline |
| Hair elasticity | Hair elongation using dynamometer | 84 days |
| Scalp sebum content | Sebumeter | Baseline |
| Scalp sebum content | Sebumeter | 56 days |
| Scalp sebum content | Sebumeter | 84 days |
| Hair diameter | Optical microscopy | Baseline |
| Hair diameter | Optical microscopy | 84 days |
| Hair loss | Pull test | Baseline |
| Hair loss | Pull test | 56 days |
| Hair loss | Pull test | 84 days |
| Hair density | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density) | Baseline |
| Hair density | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density) | 56 days |
| Hair density | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density) | 84 days |
| Hair volume | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume) | Baseline |
| Hair volume | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume) | 56 days |
| Hair volume | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume) | 84 days |
| Self-assessment of product efficacy | Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree) | 84 days |