Hydrating Efficacy and Tolerance Evaluation of a Face Cream
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Derming SRL
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Change of transepidermal water loss (TEWL) after a single product application
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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,
- •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.
Arms & Interventions
Jaluronius CS cream (Difa Cooper S.p.a, Italy)
Intervention: Jaluronius CS cream short term evaluation (Other)
Jaluronius CS cream (Difa Cooper S.p.a, Italy)
Intervention: Jaluronius CS cream long term evaluation (Other)
Outcomes
Primary Outcomes
Change of transepidermal water loss (TEWL) after a single product application
Time Frame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)
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
Change of superficial skin hydration after a single product application
Time Frame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)
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
Change of superficial skin hydration after repeated product application
Time Frame: Baseline (T0), 4 weeks (T4), 8 weeks (T8)
Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after repeated product application on the face
Change of deep skin hydration after repeated product application
Time Frame: Baseline (T0), 4 weeks (T4), 8 weeks (T8)
Variation of tissue dielectric constant value of deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) after repeated product application on the face
Secondary Outcomes
No secondary outcomes reported
Investigators
Adele Sparavigna
Dermatologist, Principal Investigator
Derming SRL