Dry and Damaged Skin Clinical Trial
Official title:
Hydrating Efficacy and Tolerance Evaluation of a Face Cream
| Verified date | June 2017 |
| Source | Derming SRL |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | May 25, 2017 |
| Est. primary completion date | May 25, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 45 Years to 60 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | DERMING | Monza | Monza-brianza |
| Lead Sponsor | Collaborator |
|---|---|
| Derming SRL |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of superficial skin hydration after a single product application | Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after a single product application on the skin area damaged by corneum stripping | Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h) | |
| Primary | Change of transepidermal water loss (TEWL) after a single product application | Variation of transepidermal water loss value measured with Tewameter® TM300 (MPA 5 Courage-Khazaka, Germany) after a single product application on the skin area damaged by corneum stripping | Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h) | |
| Primary | Change of superficial skin hydration after repeated product application | Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after repeated product application on the face | Baseline (T0), 4 weeks (T4), 8 weeks (T8) | |
| Primary | Change of deep skin hydration after repeated product application | Variation of tissue dielectric constant value of deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) after repeated product application on the face | Baseline (T0), 4 weeks (T4), 8 weeks (T8) |