Clinical trial NCT03276897: Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment
Official title: Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Face Aging/Photo Aging of Moderate Grade
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 22
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of wrinkles grade, around the eyes (Crow's feet)
timeFrame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Change of wrinkles grade of nasolabial folds
timeFrame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Change of skin surface microrelief's regularity
timeFrame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Change of skin resistance to pinching clinical score
timeFrame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Change of skin resistance to traction clinical score
timeFrame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Change of skin recovery after pinching clinical score
timeFrame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Change of skin dryness clinical score
timeFrame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Change of vascular and pigmentary homogeneity clinical score
timeFrame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Secondary outcomes:
measure: Change of roughness profilometric parameters
timeFrame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Photographic documentation (3D pictures)
timeFrame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Other outcomes:
Locations:
city: Monza
country: Italy
facility: DERMING
state: Monza-brianza
Study officials:
References: