Hydrating Efficacy and Tolerance Evaluation of a Face Cream

Not Applicable

Completed

• Conditions: Dry and Damaged Skin
• Interventions: Other: Jaluronius CS cream short term evaluation; Other: Jaluronius CS cream long term evaluation

• Registration Number: NCT03279159
• Lead Sponsor: Derming SRL

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-22
• Primary Completion: 2017-05-25
• Study Completion: 2017-05-25
• Status Verified: 2017-06
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-08
• Last Update Submitted: 2017-09-08
• Study First Posted: 2017-09-12
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Jaluronius CS cream (Difa Cooper S.p.a, Italy)	Jaluronius CS cream short term evaluation	-
Jaluronius CS cream (Difa Cooper S.p.a, Italy)	Jaluronius CS cream long term evaluation	-

Primary Outcome Measures

Name	Time	Method
Change of transepidermal water loss (TEWL) after a single product application	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	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	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	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

Trial Locations

Locations (1)

DERMING; 🇮🇹 Monza, Monza-brianza, Italy