Hypertrichosis
Conditions
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)
Interventions
OTHERActapil 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.
OTHERPlacebo
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.
Sponsors
Derming SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed