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

NCT ID: NCT03273504

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-14

Study Completion Date

2017-10-30

Brief Summary

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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

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Conditions

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Hypertrichosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)

Intervention Type 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.

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Derming SRL

OTHER

Sponsor Role lead

Responsible Party

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Adele Sparavigna

Dermatologist, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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DERMING

Milan, MI, Italy

Site Status

Countries

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Italy

Other Identifiers

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E1517

Identifier Type: -

Identifier Source: org_study_id

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