Back to results

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

Primary Purpose

Hypertrichosis

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)

Placebo

About this trial

This is an interventional treatment trial for Hypertrichosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

DERMING

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)

Arm 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.

Outcomes

Primary Outcome Measures

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)

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)

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)

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)

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03273504

First Posted

September 4, 2017

Last Updated

January 8, 2018

Sponsor

Derming SRL

1. Study Identification

Unique Protocol Identification Number

NCT03273504

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

July 14, 2017 (Actual)

Primary Completion Date

October 30, 2017 (Actual)

Study Completion Date

October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Derming SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertrichosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline of the hair density

Description

Hair density (hair number/mm2) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)

Time Frame