Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment

NCT ID: NCT03276897

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-21
• Study Completion Date: 2017-06-30

Brief Summary

Efficacy and Tolerance Evaluation of a"revitalizing" face treatment consisting of a day and a night cream

Detailed Description

Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the activity of a "revitalizing" face treatment consisting of a day and a night cream, applied for an uninterrupted period of 3 months, by female volunteers, aged 35-60 years, with aging/photo aging of moderate grade.

Conditions

Face Aging/Photo Aging of Moderate Grade

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nutriage SPF 30 day cream and Nutriage night cream

Application of the study products (day cream at the morning and night cream at the evening), for an uninterrupted period of 3 months.

Group Type: EXPERIMENTAL

Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)

Intervention Type: OTHER

A fixed quantity of both cosmetic products was applied for an uninterrupted period of 3 months, on the face included the submental area (day cream at the morning and the night cream at the evening), preferentially always at the same hour, with a mild massage

Interventions

Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)

A fixed quantity of both cosmetic products was applied for an uninterrupted period of 3 months, on the face included the submental area (day cream at the morning and the night cream at the evening), preferentially always at the same hour, with a mild massage

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• female sex,
• age 35-60 years,
• Caucasian subjects,
• presence of moderate face ritidosis,
• agreeing to present at each study visit without make-up,
• accepting to follow the instructions received by the investigator,
• accepting to not change their habits regarding food, physical activity, face cleansing and make- up use,
• agreeing not to apply or take any product or use face massages or other means known to improve skin wrinkle and skin qualities during the entire duration of the study,
• accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study,
• no participation in a similar study currently or during the previous 3 months
• accepting to sign the Informed consent form.

Exclusion Criteria

• Pregnancy,
• lactation,
• sensitivity to the test products or their ingredients (to be assessed by the investigator during the baseline visit),
• subjects whose insufficient adhesion to the study protocol is foreseeable.
• 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.).
• endocrine disease,
• hepatic disorder,
• renal disorder,
• cardiac disorder,
• pulmonary disease,
• cancer,
• neurological or psychological disease,
• inflammatory/immunosuppressive disease,
• drug allergy.
• anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago),
• using of drugs or dietary supplements able to influence the test results in the investigator opinion.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Derming SRL

OTHER

Sponsor Role: lead

Responsible Party

Adele Sparavigna

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

DERMING

Monza, Monza-brianza, Italy

Countries

Italy

Other Identifiers

E0517

Identifier Type: -

Identifier Source: org_study_id