Status:

COMPLETED

Hydrating Efficacy and Tolerance Evaluation of a Face Cream

Lead Sponsor:

Derming SRL

Conditions:

Dry and Damaged Skin

Eligibility:

All Genders

45-60 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 22 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 25 2017

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT03279159

Start Date

March 22 2017

End Date

May 25 2017

Last Update

September 12 2017

Active Locations (1)

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1

DERMING

Monza, Monza-brianza, Italy, 20900