Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo

Study Overview
=================
Brief Summary
-----------------
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)

Official Title
-----------------
Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo

Conditions
-----------------
Hypertrichosis

Intervention / Treatment
-----------------
* Other: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers female sex with hypertrichosis agreeing not to perform epilation or scrub/peeling treatment on the test area (legs) during the week preceding the inclusion good general state of health Exclusion Criteria: pregnancy lactation subjects whose insufficient adhesion to the study protocol is foreseeable sensitive skin oral contraceptive therapy started less than 1 year presence of varicose or capillary veins of surface hormonal therapies able to influence hair growth. presence of cutaneous disease on the tested area, as lesions, scars, malformations. diabetes endocrine disease hepatic disorder renal disorder cardiac disorder cancer. farmacological topical treatment and surgery and/or medical treatment on the treated side performed in the last 3 months systemic corticosteroids aspirin or non-steroid anti-inflammatory drugs (FANS) diuretic.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)<br>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. | Other: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)<br>* 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.<br>Other: Placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) |