NCT04728269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

January 14, 2021

Last Update Submit

January 28, 2021

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

  • Change in skin flora composition

    16S rRNA sequencing, qPCR

    from baseline (Day 0) at Day 21

  • Change in skin flora composition

    16S rRNA sequencing, qPCR

    from baseline (Day 0) at Day 14

Secondary Outcomes (5)

  • Skin barrier status

    Day 0, Day 14, Day 21

  • Patient Oriented SCORing Atopic Dermatitis

    Day 0, Day 14, Day 21

  • SCORing Atopic Dermatitis

    Day 0, Day 14, Day 21

  • Clinical severity of lesional areas

    Day 0, Day 14, Day 21

  • Manifestation of adverse local reactions

    From Day 0 to Day 21

Study Arms (2)

Lactibiane topic AD

EXPERIMENTAL

Cosmetical product Lactibiane Topic AD

Other: Lactibiane Topic AD

Placebo

PLACEBO COMPARATOR

Placebo made with the same base as the cosmetical product

Other: Placebo

Interventions

Lactibiane Topic ADOTHER

Application of Lactibiane topic AD twice a day (morning and evening) on one lesional area

Lactibiane topic AD
PlaceboOTHER

Application of placebo twice a day (morning and evening) on the symmetrical lesional area

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Subject with health insurance coverage according to local regulation.
  • Subject having given his written informed consent.

You may not qualify if:

  • Subject having a known hypersensitivity, allergy or contraindication to any ingredients contained within the investigational product or placebo.
  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Recherche Clinique en Immunologie - Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 28, 2021

Study Start

August 19, 2020

Primary Completion

December 9, 2020

Study Completion

December 9, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

FR(1)