CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

Study Overview
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Brief Summary
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his was a monocentric, intra-individual study, that was performed in at least 45 valid cases (50% children ≥3 YO; 50% adults). Study duration was 168 days with five (5) visits (D0, D14, D28, D84 and D168) to the research center. Primary objective Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in decrease the SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use; Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in maintenance the SCORAD value in child and adult subjects with mild atopic dermatitis after 84 and 168 days under normal conditions of use. Secondary objective Evaluation of flares quantity and severity during 84 and 168 days of use; Clinical evaluation of the improvement of skin parameters such as erythema, oedema, oozing, excoriation, lichenification, dryness and desquamation of a lesional and non-lesional skin from the same individual site by dermatologist after 14, 28, 84 and 168 days; Self-assessment of the improvement of skin parameters such as itching, tingling, burning by subjects after 14, 28, 84 and 168 days; Evaluate the perceived efficacy, cosmeticity and acceptability through a subjective evaluation questionnaire after 14, 28, 84 and 168 days; Evaluation of the improvement in skin barrier function by the loss of transepidermic water through instrumental measurements with the Tewameter® equipment on AF and UAF after 14, 28, 84 and 168 days; Evaluation of the improvement of skin moisturizing through instrumental measurements with Corneometer® equipment on AF and UAF after 14, 28, 84 and 168 days; The folliculitis incidence after 14, 28, 84 and 168 days; Assessment of the improvement of the impact of quality of life through a DLQI (Dermatology Life Quality Index) questionnaire after 14, 28, 84 and 168 days; Assessment of global tolerance through clinical dermatological evaluation and reports performed by the subjects after using the product after 14, 28, 84 and 168 days. Evaluation of total body skin dryness improvement after 14, 28, 84 and 168 days. Illustrative clinical pictures of one or two affected areas.

Official Title
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CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS: REDUCTION OF CRISES AND MAINTENANCE OF TREATMENT. STUDY UNDER NORMAL CONDITIONS OF USE AND DERMATOLOGICAL SUPERVISION

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Cosmetic study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women or men, from 3 years old, being 50% children (≥3 years old ≤ 11 years and 11 months) and 50% adults; All phototypes (a good balance between the phototypes is not mandatory, but all phototypes should be included); Diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features); Subject with mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion < 25); Subjects that have an unchanged AD routine for at least 3 months, including to systematic use of topical or systemic antihistamines, topical or systemic corticoid, cyclosporin A and other immunosuppressant. Subject able to use the study product at least once a day during all study. Subject agreeing not to change their lifestyle during the study period (overbathing, being exposed to intense stress as change job, do a fast diet to loose weight…); Subject agreeing to use only the study product and no other topical treatment for the duration of the study (usual topical or oral treatment for AD is allowed); Subject capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations; Subject available to follow the study; Subject agreeing to participate and having signed the informed consent; Subject available to be contacted by phone throughout the study. Exclusion Criteria: Breastfeeding, pregnant; Subject presenting with another dermatological condition that could interfere with clinical evaluation; Subject presenting a previous history of allergy to cosmetic products; Subject having received any systemic treatment, including PUVA therapy for atopic dermatitis in the month prior to Day 0; Subject having received phototherapy within 2 weeks before the first visit; Subject who intend to excessively expose themselves to the sun during the study; Subject known allergy to any component of the tested product (subjects will be asked if they have allergies to any ingredients and will be checked in the list if it is contained in the IP); Subject who have used any experimental treatment within 2 weeks before the first visit; Subject not presenting with the conditions needed to comply with the protocol; Subject unable to give their informed consent; Subject not available to follow the study in its entirety.

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cosmetic study|LIPIKAR BAUME LIGHT AP+M Formula: 2039055 06 Aspect: Emulsion Batch nº: RAUO0063 Expiry date: 10/2022 Application area: Face and Body Application mode: Apply to face and body twice a day. Quantity of product to be applied: About 1 flask (400g) per month|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of SCORAD Score | Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use | baseline | 
| Improvement of SCORAD Score | Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use | Day 14 | 
| Improvement of SCORAD Score | Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use | Day 28 | 
| Improvement of SCORAD Score | Maintenance of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use | Day 84 | 
| Improvement of SCORAD Score | Maintenance of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use | Day 168 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flares | Evaluation of flares quantity and severity on a scale 0=none to 4=severe | Baseline | 
| Flares | Evaluation of flares quantity and severity on a scale 0=none to 4=severe | Day 84 | 
| Flares | Evaluation of flares quantity and severity on a scale 0=none to 4=severe | Day 168 | 
| Skin parameters | Improvement on a scale 0=none to 4=severe | Baseline | 
| Skin parameters | Improvement on a scale 0=none to 4=severe | Day 14 | 
| Skin parameters | Improvement on a scale 0=none to 4=severe | Day 28 | 
| Skin parameters | Improvement on a scale 0=none to 4=severe | Day 84 | 
| Skin parameters | Improvement ona scale0=none to 4=severe | Day 156 | 
| Product acceptability | Subject questionnaire | Day 14 | 
| Product acceptability | Subject questionnaire | Day 28 | 
| Product acceptability | Subject questionnaire | Day 84 | 
| Product acceptability | Subject questionnaire | Day 156 | 
| Skin hydration | Transepidermal water loss using tewameter | Baseline | 
| Skin hydration | Transepidermal water loss using tewameter | Day 14 | 
| Skin hydration | Transepidermal water loss using tewameter | Day 28 | 
| Skin hydration | Transepidermal water loss using tewameter | Day 84 | 
| Skin hydration | Transepidermal water loss using tewameter | Day 156 | 
| Skin moisturizing | Moisturising effect using corneometer | Baseline | 
| Skin moisturizing | Moisturising effect using corneometer | Day 14 | 
| Skin moisturizing | Moisturising effect using corneometer | Day 28 | 
| Skin moisturizing | Moisturising effect using corneometer | Day 84 | 
| Skin moisturizing | Moisturising effect using corneometer | Day 156 | 
| Folliculitis | scale 0=none to 4=severe | Baseline | 
| Folliculitis | scale 0=none to 4=severe | Day 14 | 
| Folliculitis | scale 0=none to 4=severe | Day 28 | 
| Folliculitis | scale 0=none to 4=severe | Day 84 | 
| Folliculitis | scale 0=none to 4=severe | Day 156 | 
| Evolution of Quality of life over time | DLQI (Dermatology Life Quality Index) questionnaire | Baseline | 
| Evolution of Quality of life over time | DLQI (Dermatology Life Quality Index) questionnaire | Day 14 | 
| Evolution of Quality of life over time | DLQI (Dermatology Life Quality Index) questionnaire | Day 28 | 
| Evolution of Quality of life over time | DLQI (Dermatology Life Quality Index) questionnaire | Day 84 | 
| Evolution of Quality of life over time | DLQI (Dermatology Life Quality Index) questionnaire | Day 156 | 
| local tolerance reporting | reporting of events | Day 14 | 
| local tolerance reporting | reporting of events | Day 28 | 
| local tolerance reporting | reporting of events | Day 84 | 
| local tolerance reporting | reporting of events | Day 156 | 
| Total body dryness | scale | Baseline | 
| Total body dryness | scale | Day 14 | 
| Total body dryness | scale | Day 28 | 
| Total body dryness | scale | Day 84 | 
| Total body dryness | scale | Day 156 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, eczema, emollient