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Completed

NCT Number: NCT02241161

Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations

Aim of the study was to evaluate the soothing and re-epithelizing activity of a single application of topical products on experimentally induced erythema by skin stripping on the forearm (volar surface) of 20 healthy volunteers. In particular the activity of the following three cosmetic products and the relative combinations (cream and serum) were assessed: rejuvenating cream, rejuvenating serum, antioxidant serum

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DermIng SRL

Monza, 20900, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult volunteers of both sexes, aged more than 18 years old
  • Volunteers in a good general state of health in the Investigator opinion
  • Volunteers not taking drugs or undergoing surgical procedure
  • Volunteers who are giving a written informed consent.

Exclusion criteria

  • Pregnancy (only for female subjects)
  • lactation (only for female subjects)
  • change in the normal habits in the last month
  • participation in a similar study during the previous month
  • known allergy to one or several ingredients of the products on trial
  • insufficient adhesion to the study protocol
  • dermatological disease
  • clinical and significant skin condition on the test area (e.g. lesions, scars, malformations)
  • diabetes
  • endocrine disease
  • hepatic, renal or cardiac disorder
  • cancer
  • topical drugs or surgical procedure on the test areas during the previous 3 months
  • systemic corticosteroids
  • aspirin or non-steroid anti-inflammatory drugs (FANS)
  • diuretic drugs
  • antibiotics and chemotherapics
  • pshycotropic drugs
  • retinoids
  • psoralens
  • cardiologic and vascular drugs

Treatment and study plan

plantaricin a - rejuvenating cream

Other

single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes

plantaricin a - antioxidant serum

Other

single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes

plantaricin a - rejuvenating serum

Other

single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes

Primary outcomes

  1. Clinical evaluation of skin erythema: change from baseline, 1 hour after products application (T1h vs. T0)

    Time frame: After 1 (T1h) hour from products application

    Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth)

Secondary outcomes

  1. Clinical evaluation of skin erythema: change from baseline, 6 hours from products application (T6h vs. T0)

    Time frame: After 6 (T6h) hours from products application

    Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth)

  2. Clinical evaluation of skin erythema: change from baseline, after 24 hours from products application (T24h vs. T0)

    Time frame: After 24 (T24h) hours from products application

    Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth)

  3. Optical densitometry: change from baseline, after 1hour from products application (T1h vs. T0)

    Time frame: After 1 (T1h) hour from products application

    The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan

  4. Optical densitometry: change from baseline, 6 hours from products application (T6h vs. T0)

    Time frame: After 6 (T6h) hours from products application

    The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan

  5. Optical densitometry: change from baseline, 24 hours from products application (T24h vs.T0)

    Time frame: After 24 (T24h) hours from products application

    The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan

  6. Surface microrelief evaluation: change from baseline, after 1 hour from products application (T1h vs.T0)

    Time frame: After 1 (Th1) hour from products application

    Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope.

  7. Surface microrelief evaluation: change from baseline, 6 hours from products application (T6h vs. T0)

    Time frame: After 6 (T6h) hours from products application

    Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope.

  8. Surface microrelief evaluation: change from baseline, after 24 hours from products application (T24h) hours from products application vs.T0)

    Time frame: After 24 hours (T24h) from products application

    Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope.

Sponsors and collaborators

Lead sponsor

Derming SRL

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2014
Registry last updated
Sep 16, 2014

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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