Efficacy and Tolerance Evaluation of a Topical "Revitalizing" Face Day Cream
NCT ID: NCT02230397
Last Updated: 2014-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
33 participants
INTERVENTIONAL
2013-10-31
2013-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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plantaricin a (active product)
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.
plantaricin a (active product)
Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage
placebo product
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
placebo product
Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage
Interventions
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plantaricin a (active product)
Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage
placebo product
Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
65 Years
FEMALE
Yes
Sponsors
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Derming SRL
OTHER
Responsible Party
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Principal Investigators
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Adele Sparavigna, Doctor
Role: PRINCIPAL_INVESTIGATOR
Derming SRL
Locations
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DermIng SRL
Monza, Monza, Italy
Countries
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References
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Related Links
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Sponsor
Other Identifiers
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E2713
Identifier Type: -
Identifier Source: org_study_id
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