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
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrichosis
Eligibility Criteria
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
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
Baseline (T0), 1 month (T1), 3 months (T3)
Title
Change from baseline of the percentage of terminal hair
Description
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)
Time Frame
Baseline (T0), 1 month (T1), 3 months (T3)
Title
Change from baseline of the percentage of vellus hair
Description
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)
Time Frame
Baseline (T0), 1 month (T1), 3 months (T3)
Title
Change from baseline of hair regrowth speed
Description
Hair regrowth speed (mm/die) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Time Frame
Baseline (T0), 1 month (T1), 3 months (T3)
Secondary Outcome Measure Information:
Title
Change from baseline of superficial skin hydration
Description
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.
Time Frame
Baseline (T0), 1 month (T1), 3 months (T3)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
DERMING
City
Milano
State/Province
MI
ZIP/Postal Code
20149
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
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