Clinical trial NCT02241161: Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations
Official title: Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: skin eythema
rejuvenating cream
rejuvenating serum
antioxidant serum
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Clinical evaluation of skin erythema: change from baseline, 1 hour after products application (T1h vs. T0)
timeFrame: After 1 (T1h) hour from products application
Secondary outcomes:
measure: Clinical evaluation of skin erythema: change from baseline, 6 hours from products application (T6h vs. T0)
timeFrame: After 6 (T6h) hours from products application
measure: Clinical evaluation of skin erythema: change from baseline, after 24 hours from products application (T24h vs. T0)
timeFrame: After 24 (T24h) hours from products application
measure: Optical densitometry: change from baseline, after 1hour from products application (T1h vs. T0)
timeFrame: After 1 (T1h) hour from products application
measure: Optical densitometry: change from baseline, 6 hours from products application (T6h vs. T0)
timeFrame: After 6 (T6h) hours from products application
measure: Optical densitometry: change from baseline, 24 hours from products application (T24h vs.T0)
timeFrame: After 24 (T24h) hours from products application
measure: Surface microrelief evaluation: change from baseline, after 1 hour from products application (T1h vs.T0)
timeFrame: After 1 (Th1) hour from products application
measure: Surface microrelief evaluation: change from baseline, 6 hours from products application (T6h vs. T0)
timeFrame: After 6 (T6h) hours from products application
measure: Surface microrelief evaluation: change from baseline, after 24 hours from products application (T24h) hours from products application vs.T0)
timeFrame: After 24 hours (T24h) from products application
Other outcomes:
Locations:
city: Monza
country: Italy
facility: DermIng SRL
Study officials:
affiliation: Derming SRL
name: Adele Sparavigna, Doctor
role: PRINCIPAL_INVESTIGATOR
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