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Hydrating Efficacy and Tolerance Evaluation of a Face Cream

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ClinicalTrials.gov Identifier: NCT03279159
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Adele Sparavigna, 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).


Condition or disease Intervention/treatment Phase
Dry and Damaged Skin Other: Jaluronius CS cream short term evaluation Other: Jaluronius CS cream long term evaluation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydrating Efficacy and Tolerance Evaluation of a Face Cream
Actual Study Start Date : March 22, 2017
Actual Primary Completion Date : May 25, 2017
Actual Study Completion Date : May 25, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Jaluronius CS cream (Difa Cooper S.p.a, Italy) Other: Jaluronius CS cream short term evaluation
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).
Other: Jaluronius CS cream long term evaluation
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)



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279159


Locations
Italy
DERMING
Monza, Monza-brianza, Italy, 20900
Sponsors and Collaborators
Derming SRL

Responsible Party: Adele Sparavigna, Dermatologist, Principal Investigator, Derming SRL
ClinicalTrials.gov Identifier: NCT03279159     History of Changes
Other Study ID Numbers: E0617
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dimenhydrinate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action