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

September 12, 2014 updated by: Derming SRL
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monza, Italy, 20900
        • DermIng SRL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: plantaricin a - rejuvenating cream
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
Other: plantaricin a - rejuvenating cream
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
Active Comparator: plantaricin a - rejuvenating serum
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
Other: plantaricin a - rejuvenating serum
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
Active Comparator: plantaricin a - antioxidant serum
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
Other: plantaricin a - antioxidant serum
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
Active Comparator: plantaricin a (rejuvenating cream +rejuvenating serum)
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
Other: plantaricin a - rejuvenating cream
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
Other: plantaricin a - rejuvenating serum
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
Active Comparator: plantaricin a (rejuvenating cream + antioxidant serum)
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
Other: plantaricin a - rejuvenating cream
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
Other: plantaricin a - antioxidant serum
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
After 1 (T1h) hour from products application

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
After 6 (T6h) hours from products application
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)
After 24 (T24h) hours from products application
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
After 1 (T1h) hour from products application
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
After 6 (T6h) hours from products application
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
After 24 (T24h) hours from products application
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.
After 1 (Th1) hour from products application
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.
After 6 (T6h) hours from products application
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.
After 24 hours (T24h) from products application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Derming SRL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2913

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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