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

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 Overview

• Status: Completed
• Conditions: Hypertrichosis
• Intervention / Treatment: Other: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20149
      • DERMING

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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)

Collaborators and Investigators

• Sponsor: Derming SRL

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2017
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Hypertrichosis
• Other Study ID Numbers: E1517

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No