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

Derming SRL24 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertrichosis

Interventions

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.

PlaceboOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

DERMING

Milan, MI, Italy

Outcomes

Primary Outcomes

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)