Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
- Conditions
- Hypertrichosis
- Interventions
- Other: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)Other: Placebo
- Registration Number
- NCT03273504
- Lead Sponsor
- Derming SRL
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) 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. Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) Placebo 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.
- Primary Outcome Measures
Name Time Method Change from baseline of the hair density 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 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 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 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 Outcome Measures
Name Time Method Change from baseline of superficial skin hydration Baseline (T0), 1 month (T1), 3 months (T3) 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.
Trial Locations
- Locations (1)
DERMING
🇮🇹Milano, MI, Italy