Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertrichosis
- Sponsor
- Derming SRL
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change from baseline of the hair density
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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)
Investigators
Adele Sparavigna
Dermatologist, Principal Investigator
Derming SRL
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.
- •endocrine disease
- •hepatic disorder
Outcomes
Primary Outcomes
Change from baseline of the hair density
Time Frame: Baseline (T0), 1 month (T1), 3 months (T3)
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 hair regrowth speed
Time Frame: Baseline (T0), 1 month (T1), 3 months (T3)
Hair regrowth speed (mm/die) 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
Time Frame: Baseline (T0), 1 month (T1), 3 months (T3)
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
Time Frame: Baseline (T0), 1 month (T1), 3 months (T3)
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)
Secondary Outcomes
- Change from baseline of superficial skin hydration(Baseline (T0), 1 month (T1), 3 months (T3))