Clinical trial NCT05783453: CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS
Official title: CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS: REDUCTION OF CRISES AND MAINTENANCE OF TREATMENT. STUDY UNDER NORMAL CONDITIONS OF USE AND DERMATOLOGICAL SUPERVISION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis, eczema, emollient
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children and adult subjects with mild atopic dermatitis

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of SCORAD Score
timeFrame: baseline
measure: Improvement of SCORAD Score
timeFrame: Day 14
measure: Improvement of SCORAD Score
timeFrame: Day 28
measure: Improvement of SCORAD Score
timeFrame: Day 84
measure: Improvement of SCORAD Score
timeFrame: Day 168
Secondary outcomes:
measure: Flares
timeFrame: Baseline
measure: Flares
timeFrame: Day 84
measure: Flares
timeFrame: Day 168
measure: Skin parameters
timeFrame: Baseline
measure: Skin parameters
timeFrame: Day 14
measure: Skin parameters
timeFrame: Day 28
measure: Skin parameters
timeFrame: Day 84
measure: Skin parameters
timeFrame: Day 156
measure: Product acceptability
timeFrame: Day 14
measure: Product acceptability
timeFrame: Day 28
measure: Product acceptability
timeFrame: Day 84
measure: Product acceptability
timeFrame: Day 156
measure: Skin hydration
timeFrame: Baseline
measure: Skin hydration
timeFrame: Day 14
measure: Skin hydration
timeFrame: Day 28
measure: Skin hydration
timeFrame: Day 84
measure: Skin hydration
timeFrame: Day 156
measure: Skin moisturizing
timeFrame: Baseline
measure: Skin moisturizing
timeFrame: Day 14
measure: Skin moisturizing
timeFrame: Day 28
measure: Skin moisturizing
timeFrame: Day 84
measure: Skin moisturizing
timeFrame: Day 156
measure: Folliculitis
timeFrame: Baseline
measure: Folliculitis
timeFrame: Day 14
measure: Folliculitis
timeFrame: Day 28
measure: Folliculitis
timeFrame: Day 84
measure: Folliculitis
timeFrame: Day 156
measure: Evolution of Quality of life over time
timeFrame: Baseline
measure: Evolution of Quality of life over time
timeFrame: Day 14
measure: Evolution of Quality of life over time
timeFrame: Day 28
measure: Evolution of Quality of life over time
timeFrame: Day 84
measure: Evolution of Quality of life over time
timeFrame: Day 156
measure: local tolerance reporting
timeFrame: Day 14
measure: local tolerance reporting
timeFrame: Day 28
measure: local tolerance reporting
timeFrame: Day 84
measure: local tolerance reporting
timeFrame: Day 156
measure: Total body dryness
timeFrame: Baseline
measure: Total body dryness
timeFrame: Day 14
measure: Total body dryness
timeFrame: Day 28
measure: Total body dryness
timeFrame: Day 84
measure: Total body dryness
timeFrame: Day 156
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: CIDP
Study officials:
affiliation: CIDP Brasil
name: Daniele Miranda, MD
role: STUDY_DIRECTOR
References: