Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Derming SRL
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Clinical evaluation of skin erythema: change from baseline, 1 hour after products application (T1h vs. T0)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
- •endocrine disease
- •hepatic, renal or cardiac disorder
- •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
Arms & Interventions
plantaricin 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
Intervention: plantaricin a - rejuvenating cream (Other)
plantaricin 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
Intervention: plantaricin a - rejuvenating serum (Other)
plantaricin 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
Intervention: plantaricin a - antioxidant serum (Other)
plantaricin a (rejuvenating cream +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
Intervention: plantaricin a - rejuvenating cream (Other)
plantaricin a (rejuvenating cream +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
Intervention: plantaricin a - rejuvenating serum (Other)
plantaricin a (rejuvenating cream + 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
Intervention: plantaricin a - rejuvenating cream (Other)
plantaricin a (rejuvenating cream + 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
Intervention: plantaricin a - antioxidant serum (Other)
Outcomes
Primary Outcomes
Clinical evaluation of skin erythema: change from baseline, 1 hour after products application (T1h vs. T0)
Time Frame: 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 Outcomes
- Clinical evaluation of skin erythema: change from baseline, 6 hours from products application (T6h vs. T0)(After 6 (T6h) hours from products application)
- Surface microrelief evaluation: change from baseline, 6 hours from products application (T6h vs. T0)(After 6 (T6h) hours from products application)
- 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)
- Clinical evaluation of skin erythema: change from baseline, after 24 hours from products application (T24h vs. T0)(After 24 (T24h) hours from products application)
- Optical densitometry: change from baseline, after 1hour from products application (T1h vs. T0)(After 1 (T1h) hour from products application)
- Optical densitometry: change from baseline, 6 hours from products application (T6h vs. T0)(After 6 (T6h) hours from products application)
- Optical densitometry: change from baseline, 24 hours from products application (T24h vs.T0)(After 24 (T24h) hours from products application)
- Surface microrelief evaluation: change from baseline, after 1 hour from products application (T1h vs.T0)(After 1 (Th1) hour from products application)