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Hydrating Efficacy and Tolerance Evaluation of a Face Cream

D

Derming

Status

Completed

Conditions

Dry and Damaged Skin

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

18 patients

Sex

All

Ages

45 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Jaluronius CS cream (Difa Cooper S.p.a, Italy)
Experimental group
Treatment:
Other: Jaluronius CS cream long term evaluation
Other: Jaluronius CS cream short term evaluation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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