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

Not Applicable

Completed

• Conditions: Hypertrichosis

• Registration Number: NCT03273504
• Lead Sponsor: Derming SRL

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-14
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-04
• Study First Posted: 2017-09-06
• Primary Completion: 2017-10-30
• Study Completion: 2017-10-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline of the hair density	Baseline (T0), 1 month (T1), 3 months (T3)	Hair density (hair number/mm2) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Change from baseline of hair regrowth speed	Baseline (T0), 1 month (T1), 3 months (T3)	Hair regrowth speed (mm/die) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Change from baseline of the percentage of terminal hair	Baseline (T0), 1 month (T1), 3 months (T3)	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)
Change from baseline of the percentage of vellus hair	Baseline (T0), 1 month (T1), 3 months (T3)	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)

Secondary Outcome Measures

Name	Time	Method
Change from baseline of superficial skin hydration	Baseline (T0), 1 month (T1), 3 months (T3)	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.

Trial Locations

Locations (1)

DERMING; 🇮🇹 Milano, MI, Italy