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

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: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Lactibiane Topic AD; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: PiLeJe

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Actual): December 9, 2020
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID 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