Efficacy and Tolerance Evaluation of a Topical "Revitalizing" Face Day Cream

Derming

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Other: placebo product; Other: plantaricin a (active product)

Study type: Interventional

Funder types: Other

Identifiers

NCT02230397

E2713

Details and patient eligibility

About

Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the "revitalizing" activity of a face cream applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by healthy female volunteers aged 45-55 years with face ritidosis and women aged 55-65 years not habitual user of antiage-creams.

The study foresaw the comparison within subjects of the study product versus placebo (half face method).

It was also aim of this study to evaluate products efficacy and cosmetic acceptability by the volunteers and tolerance both by investigator and volunteers.

Enrollment: 33 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• female healthy subjects
• age 45-55 years
• women aged 55-65 years who are not habitual user of antiage-creams
• presence of moderate face ritidosis
• agreeing to present at each study visit without make-up
• accepting to not change their habits regarding food, physical activity, face cleansing and make- up use
• accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study
• accepting to sign the Informed consent form

Exclusion criteria

• pregnancy
• lactation
• change in the normal habits regarding foods, physical activity, face cleansing and make-up use during the month preceding the test
• sensitivity to the test products or theirs ingredients
• subjects whose insufficient adhesion to the study protocol is foreseeable
• participation in a similar study actually or during the previous 3 months
• change in the normal life habits during the month preceding the inclusion
• dermatological disease (dermatitis; presence of cutaneous disease on the tested area, as lesions, scars, malformations; recurrent facial/labial herpes)
• clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.)
• diabetes
• endocrine disease
• hepatic disorder
• renal disorder
• cardiac disorder
• pulmonary disease
• cancer
• neurological or psychological disease
• inflammatory/immunosuppressive disease
• drug allergy
• drugs/cutaneous medical or surgical procedures at level of the tested area during the previous 3 months
• anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with except of contraceptive or hormonal treatment starting from at least 1 year);
• assumption of drugs able to influence the test results in the investigator opinion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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33 participants in 2 patient groups

plantaricin a (active product)

Other group

Description:

Volunteers applied the active product for an uninterrupted period of 8 weeks (on the right or on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage.

Treatment:

Other: plantaricin a (active product)

placebo product

Other group

Description:

Volunteers applied the placebo product for an uninterrupted period of 8 weeks (on the right or on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage

Treatment:

Other: placebo product