Hydrating Efficacy and Tolerance Evaluation of a Face Cream

NCT03279159 | Completed

• 1 other identifier: E0617
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Dry and Damaged Skin

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Jaluronius CS cream (Difa Cooper S.p.a, Italy)

EXPERIMENTAL

Other: Jaluronius CS cream short term evaluation; Other: Jaluronius CS cream long term evaluation

Interventions

Jaluronius CS cream short term evaluation OTHER

Short term evaluation to investigate the hydrating activity of a single application of the study product on the forearms (volar surface) after repeated stripping procedure,measured immediately after stripping execution (T0i), 1,8 and 24 hour/s after product application (T1h, T8h and T24h).

Jaluronius CS cream (Difa Cooper S.p.a, Italy)

Jaluronius CS cream long term evaluation OTHER

Long term evaluation to investigate the hydrating activity of the repeated application of the study product on the face (twice a day, for an uninterrupted period of 8 weeks), measured at basal visit (T0) and after 4 and 8 week-treatment (T4, T8)

Jaluronius CS cream (Difa Cooper S.p.a, Italy)

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Monza, Monza-brianza, 20900, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist, Principal Investigator

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 12, 2017
• Study Start: March 22, 2017
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-06

Locations

IT (1)