Clinical trial NCT04728269: Exploratory Study on Lactibiane Topic AD on Skin Flora and Barrier Reinforcement in Mild to Moderate Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: PiLeJe
Sponsor class: INDUSTRY
First posted: 2021-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in skin flora composition
timeFrame: from baseline (Day 0) at Day 21
measure: Change in skin flora composition
timeFrame: from baseline (Day 0) at Day 14
Secondary outcomes:
measure: Skin barrier status
timeFrame: Day 0, Day 14, Day 21
measure: Patient Oriented SCORing Atopic Dermatitis
timeFrame: Day 0, Day 14, Day 21
measure: SCORing Atopic Dermatitis
timeFrame: Day 0, Day 14, Day 21
measure: Clinical severity of lesional areas
timeFrame: Day 0, Day 14, Day 21
measure: Manifestation of adverse local reactions
timeFrame: From Day 0 to Day 21
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Unité de Recherche Clinique en Immunologie - Lyon Sud
Study officials:
References: