Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations

Derming

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Other: plantaricin a - rejuvenating cream; Other: plantaricin a - antioxidant serum; Other: plantaricin a - rejuvenating serum

Study type: Interventional

Funder types: Other

Identifiers

NCT02241161

E2913

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 5 patient groups

plantaricin a - rejuvenating cream

Active Comparator group

Description:

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

Treatment:

Other: plantaricin a - rejuvenating cream

plantaricin a - rejuvenating serum

Active Comparator group

Description:

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

Treatment:

Other: plantaricin a - rejuvenating serum

plantaricin a - antioxidant serum

Active Comparator group

Description:

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

Treatment:

Other: plantaricin a - antioxidant serum

plantaricin a (rejuvenating cream +rejuvenating serum)

Active Comparator group

Description:

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

Treatment:

Other: plantaricin a - rejuvenating serum

Other: plantaricin a - rejuvenating cream

plantaricin a (rejuvenating cream + antioxidant serum)

Active Comparator group

Description:

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

Treatment:

Other: plantaricin a - rejuvenating cream

Other: plantaricin a - antioxidant serum