Exploratory Study on Lactibiane Topic AD on Skin Flora and Barrier Reinforcement in Mild to Moderate Atopic Dermatitis

January 28, 2021 updated by: PiLeJe

Exploratory Study to Assess the Impact of a Cosmetic Product (Lactibiane Topic AD) on Skin Flora and Skin Reinforcement Barrier in Mild to Moderate Atopic Dermatitis

This exploratory study aims to evaluate the impact of a cosmetic product (Lactibiane Topic AD) vs placebo on skin flora and skin reinforcement barrier in mild to moderate atopic dermatitis using biometrological, biological and clinical parameters.

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.
10

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.
  • Not Applicable

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

  • France
      • Pierre-Bénite, France, 69495
        • Unité de Recherche Clinique en Immunologie - Lyon Sud

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject diagnosed with mild to moderate AD defined as SCORAD≤40 (Eichenfield et al. JAAD 2014).
  • Subject with at least two symmetric AD lesions with comparable severity: Located either on upper extremities (left and right arms except hands) or lower extremities (left and right legs except feet), With an erythema ≥ 1 (mild to severe intensity), With a lesional area score ≥ 4 on both lesions with an authorized delta of two points between the two lesions, With a sufficient extent to allow all the investigations.
  • Subject with I, II, III or IV skin phototype (according to Fitzpatrick's scale).
  • For woman of childbearing potential (defined as all women physiologically capable of becoming pregnant): Negative urine pregnancy test at inclusion visit. Use of a highly effective method of birth control* during the study. * A highly effective method of birth control is defined as one which results in a low failure rate (less than 1%) when used consistently and correctly, such as implants, combined oral contraceptives, intrauterine device, double barrier methods (e.g. condom with spermicide), sexual abstinence or vasectomized partner.
  • Subject with health insurance coverage according to local regulation.
  • Subject having given his written informed consent.

Exclusion Criteria:

  • Subject having a known hypersensitivity, allergy or contraindication to any ingredients contained within the investigational product or placebo.
  • Subject having exposed his skin to natural or artificial UV within 8 weeks prior to the inclusion visit or intending to expose his skin during the study.
  • Subject having performed phototherapy within 8 weeks prior to the inclusion visit or intending to perform phototherapy during the study.
  • Subject having performed another physical treatment (e.g radiotherapy…) on the investigational areas within 6 months prior to the inclusion visit or intending to perform it during the study.
  • Subject treated with systemic non-steroidal anti-inflammatory drugs (≥3 days) within 1 week before the inclusion visit.
  • Subject treated with biological immunosuppressive drugs within 12 weeks prior to the inclusion visit or intending to be treated with it during the study.
  • Subject treated with non-biological immunosuppressive drugs within 4 weeks prior to the inclusion visit or intending to be treated with it during the study.
  • Subject treated with systemic corticoids within 1 week prior to the inclusion visit or planed during the study.
  • Subject treated with systemic antibiotics within 7 days prior to the inclusion visit or planed during the study.
  • Subject having applied topical immunomodulators, non-steroidal anti-inflammatory, corticoids or antihistamines on investigational limbs within 1 weeks prior to the inclusion visit.
  • Subject having applied topical antibiotics or disinfectants on investigational limbs within 2 weeks prior to the inclusion visit.
  • Subject having applied any other topical and/or care product after the last grooming prior to the inclusion visit.
  • Subject having applied water or care product (except hands cleaning) within 12 hours prior to the inclusion visit.
  • Subject having started, modified or stopped any other treatment/product within 4 weeks prior to the inclusion visit or intending to do so during the study that according to the investigator's judgment, could interfere with study results.
  • Subject having significant medical condition that according to the investigator's judgment, deems inappropriate for study participation (e.g present or past malignancy, present or past skin condition…).
  • Subject having significant dermatological condition or sign (e.g disease, scare, abundant hairiness, tanning mark…) that according to the investigator's judgment, could limit the observations or/and interfere with the interpretations.
  • Subject taking part or having participated in another clinical study within 2 weeks prior to the inclusion visit.
  • Subject under legal guardianship or incapacitation.
  • Subject linguistically or psychologically unable of signing informed consent form and unable to comply with the protocol requirements according to the investigator's judgment.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

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.
Experimental: Lactibiane topic AD
Cosmetical product Lactibiane Topic AD
Other: Lactibiane Topic AD
Application of Lactibiane topic AD twice a day (morning and evening) on one lesional area
Placebo Comparator: Placebo
Placebo made with the same base as the cosmetical product
Other: Placebo
Application of placebo twice a day (morning and evening) on the symmetrical lesional area

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
Change in skin flora composition
Time Frame: from baseline (Day 0) at Day 21
16S rRNA sequencing, qPCR
from baseline (Day 0) at Day 21
Change in skin flora composition
Time Frame: from baseline (Day 0) at Day 14
16S rRNA sequencing, qPCR
from baseline (Day 0) at Day 14

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
Skin barrier status
Time Frame: Day 0, Day 14, Day 21
TransEpidermal Water Loss (TEWL)
Day 0, Day 14, Day 21
Patient Oriented SCORing Atopic Dermatitis
Time Frame: Day 0, Day 14, Day 21
Patient Oriented SCORing Atopic Dermatitis (POSCORAD): 0 - 103 (Higher values represent a worse outcome)
Day 0, Day 14, Day 21
SCORing Atopic Dermatitis
Time Frame: Day 0, Day 14, Day 21
SCORing Atopic Dermatitis (SCORAD) : 0 - 103 (Higher values represent a worse outcome)
Day 0, Day 14, Day 21
Clinical severity of lesional areas
Time Frame: Day 0, Day 14, Day 21
Scoring of lesional area by subject and investigator : 0-18 (Higher values represent a worse outcome)
Day 0, Day 14, Day 21
Manifestation of adverse local reactions
Time Frame: From Day 0 to Day 21
Subjects will use a diary to document any potential adverse reactions observed after product application
From Day 0 to Day 21

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.
PiLeJe

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 (Actual)

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.
August 19, 2020

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 9, 2020

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 9, 2020

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).
January 14, 2021

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.
January 23, 2021

First Posted (Actual)

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.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

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.
February 2, 2021

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.
January 28, 2021

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.
January 1, 2021

More Information

Terms related to this study

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.
  • DEABIOM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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