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Completed

NCT Number: NCT03276897

Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment

Efficacy and Tolerance Evaluation of a"revitalizing" face treatment consisting of a day and a night cream

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Key information

Conditions

Face Aging/Photo Aging of Moderate Grade

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DERMING

Monza, Monza-brianza, 20900, Italy

About this study

Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the activity of a "revitalizing" face treatment consisting of a day and a night cream, applied for an uninterrupted period of 3 months, by female volunteers, aged 35-60 years, with aging/photo aging of moderate grade.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female sex,
  • age 35-60 years,
  • Caucasian subjects,
  • presence of moderate face ritidosis,
  • 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,
  • lactation,
  • sensitivity to the test products or their 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.

Treatment and study plan

Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)

Other

A fixed quantity of both cosmetic products was applied for an uninterrupted period of 3 months, on the face included the submental area (day cream at the morning and the night cream at the evening), preferentially always at the same hour, with a mild massage

Primary outcomes

  1. Change of wrinkles grade, around the eyes (Crow's feet)

    Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

    Variation of wrinkles grade from baseline of the Glogau's reference photographic scale (visual score from 1-4) where:

    • Type 1: early wrinkles
    • Type 2: wrinkle in motion
    • Type 3: wrinkles at rest
    • Type 4: Only wrinkles

  2. Change of wrinkles grade of nasolabial folds

    Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

    Variation of wrinkles grade from baseline of the Lemperle's reference photographic scale (visual score from 1-6) where:

    • Grade 1: no wrinkles
    • Grade 2: just perceptible wrinkles
    • Grade 3: shallow wrinkles
    • Grade 4: moderately deep wrinkles
    • Grade 5: deep wrinkles, well-defined folds
    • Grade 6: very deep wrinkles, redundant fold

  3. Change of skin surface microrelief's regularity

    Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

    Variation of skin surface microrelief's regularity grade from baseline of cheek surface microrelief photographic scale where:

    • Grade 1:very regular
    • Grade 2: regular
    • Grade 3: irregular
    • Grade 4: very irregular.

  4. Change of skin resistance to pinching clinical score

    Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

    The evaluation was performed at level of cheek (malar region) according to the following score:

    0 = very important

    • = important
    • = moderate
    • = weak
    • = very weak

  5. Change of skin resistance to traction clinical score

    Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

    The evaluation was performed at level of cheek (malar region) according to the following score:

    0 = very important

    • = important
    • = moderate
    • = weak
    • = very weak

  6. Change of skin recovery after pinching clinical score

    Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

    The evaluation was performed at level of cheek (malar region) according to the following score:

    0 = very important

    • = important
    • = moderate
    • = weak
    • = very weak

  7. Change of skin dryness clinical score

    Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

    Clinical evaluation of skin dryness was performed according to the following score:

    0 = very hydrated skin

    • = hydrated skin
    • = normal skin
    • = kindly dry skin
    • = dry skin
    • = very dry skin

  8. Change of vascular and pigmentary homogeneity clinical score

    Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

    Homogeneity grade was determined according to specific reference clinical and photographic scales and to the following clinical score:

    0 = very homogeneous

    • = homogeneous
    • = quite not homogeneous
    • = not homogeneous
    • = very not homogeneous
    • = marked not homogeneous

Secondary outcomes

  1. Change of roughness profilometric parameters

    Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

    Crow's feet profilometric parameters measured by Primos compact portable device (GFMesstechnik). Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth.

  2. Photographic documentation (3D pictures)

    Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

    Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.

Sponsors and collaborators

Lead sponsor

Derming SRL

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2017
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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