Healthy
Conditions
Keywords
skin eythema, rejuvenating cream, rejuvenating serum, antioxidant serum
Brief summary
Aim of the study was to evaluate the soothing and re-epithelizing activity of a single application of topical products on experimentally induced erythema by skin stripping on the forearm (volar surface) of 20 healthy volunteers. In particular the activity of the following three cosmetic products and the relative combinations (cream and serum) were assessed: rejuvenating cream, rejuvenating serum, antioxidant serum
Interventions
OTHERplantaricin a - rejuvenating cream
single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
OTHERplantaricin a - antioxidant serum
single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
OTHERplantaricin a - rejuvenating serum
single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
Sponsors
Derming SRL
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult volunteers of both sexes, aged more than 18 years old * Volunteers in a good general state of health in the Investigator opinion * Volunteers not taking drugs or undergoing surgical procedure * Volunteers who are giving a written informed consent.
Exclusion criteria
* Pregnancy (only for female subjects) * lactation (only for female subjects) * change in the normal habits in the last month * participation in a similar study during the previous month * known allergy to one or several ingredients of the products on trial * insufficient adhesion to the study protocol * dermatological disease * clinical and significant skin condition on the test area (e.g. lesions, scars, malformations) * diabetes * endocrine disease * hepatic, renal or cardiac disorder * cancer * topical drugs or surgical procedure on the test areas during the previous 3 months * systemic corticosteroids * aspirin or non-steroid anti-inflammatory drugs (FANS) * diuretic drugs * antibiotics and chemotherapics * pshycotropic drugs * retinoids * psoralens * cardiologic and vascular drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evaluation of skin erythema: change from baseline, 1 hour after products application (T1h vs. T0) | After 1 (T1h) hour from products application | Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evaluation of skin erythema: change from baseline, after 24 hours from products application (T24h vs. T0) | After 24 (T24h) hours from products application | Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth) |
| Optical densitometry: change from baseline, after 1hour from products application (T1h vs. T0) | After 1 (T1h) hour from products application | The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan |
| Optical densitometry: change from baseline, 6 hours from products application (T6h vs. T0) | After 6 (T6h) hours from products application | The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan |
| Clinical evaluation of skin erythema: change from baseline, 6 hours from products application (T6h vs. T0) | After 6 (T6h) hours from products application | Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth) |
| Surface microrelief evaluation: change from baseline, after 1 hour from products application (T1h vs.T0) | After 1 (Th1) hour from products application | Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope. |
| Surface microrelief evaluation: change from baseline, 6 hours from products application (T6h vs. T0) | After 6 (T6h) hours from products application | Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope. |
| Surface microrelief evaluation: change from baseline, after 24 hours from products application (T24h) hours from products application vs.T0) | After 24 hours (T24h) from products application | Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope. |
| Optical densitometry: change from baseline, 24 hours from products application (T24h vs.T0) | After 24 (T24h) hours from products application | The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan |
Countries
Italy
Outcome results
None listed