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

Hypertrichosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273504
• Other study ID #: E1517
• Status: Completed
• Phase: N/A
• First received: September 4, 2017
• Last updated: January 8, 2018
• Start date: July 14, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: January 2018
• Source: Derming SRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertrichosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	DERMING	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Derming SRL

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)