Status:
COMPLETED
Efficacy and Tolerance Evaluation of a Topical "Revitalizing" Face Day Cream
Lead Sponsor:
Derming SRL
Conditions:
Healthy
Eligibility:
FEMALE
45-65 years
Phase:
PHASE3
Brief Summary
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 peri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02230397
Start Date
October 1 2013
End Date
December 1 2013
Last Update
September 3 2014
Active Locations (1)
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1
DermIng SRL
Monza, Monza, Italy, 20900