Clinical trial NCT03279159: Hydrating Efficacy and Tolerance Evaluation of a Face Cream
Official title: Hydrating Efficacy and Tolerance Evaluation of a Face Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry and Damaged Skin
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 18
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and hydrating activity of a face topic product, to be applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the inclusion and exclusion criteria required by the study procedure .

It was also aim of this study to evaluate the hydrating activity of a single product application on the skin damaged by repeated stripping corneum (short term evaluation versus untreated control area).


Eligibility criteria: Inclusion Criteria:

* both sexes,
* age 45-60 years,
* caucasian subjects,
* 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 (only for female subjects),
* lactation (only for female subjects),
* sensitivity to the test product or its 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 superficial skin hydration after a single product application
timeFrame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)
measure: Change of transepidermal water loss (TEWL) after a single product application
timeFrame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)
measure: Change of superficial skin hydration after repeated product application
timeFrame: Baseline (T0), 4 weeks (T4), 8 weeks (T8)
measure: Change of deep skin hydration after repeated product application
timeFrame: Baseline (T0), 4 weeks (T4), 8 weeks (T8)
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: DERMING
state: Monza-brianza
Study officials:
References: