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

Derming

Status: Completed

Conditions: Hypertrichosis

Treatments: Other: Placebo; Other: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)

Study type: Interventional

Funder types: Other

Identifiers

NCT03273504

E1517

Details and patient eligibility

About

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)

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)

Experimental group

Description:

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.

Treatment:

Other: Placebo

Other: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)