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Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the activity on hair regrowth of a topical cosmetic product versus placebo (comparison within subjects)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) | Experimental | Comparison within subjects of Actapil Corpo Spray versus Placebo. The study product will be applied twice a dayon the right or left leg (tibialis area) according to a randomisation list. The placebo product will be applied in the same way, on the controlateral leg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) | Other | The study product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the right or left leg (tibialis area) according to a randomisation list. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of the hair density | Hair density (hair number/mm2) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan) | Baseline (T0), 1 month (T1), 3 months (T3) |
| Change from baseline of the percentage of terminal hair | Percentage of terminal hair (terminal hair has a diameter >0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan) | Baseline (T0), 1 month (T1), 3 months (T3) |
| Change from baseline of the percentage of vellus hair | Percentage of vellus hair (terminal hair has a diameter <0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan) | Baseline (T0), 1 month (T1), 3 months (T3) |
| Change from baseline of hair regrowth speed | Hair regrowth speed (mm/die) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan) | Baseline (T0), 1 month (T1), 3 months (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of superficial skin hydration | Skin electrical capacitance value is measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level. | Baseline (T0), 1 month (T1), 3 months (T3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DERMING | Milan | MI | 20149 | Italy |
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| ID | Term |
|---|---|
| D006983 | Hypertrichosis |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo | Other | The placebo product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the controlateral leg (tibialis area) right or left leg according to a randomisation list. |
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