The aim of this study is to evaluate the efficacy and tolerance of a face and body emollient cream in individuals (infants, children, adults) with phototypes IV-VI presenting mild to moderate atopic dermatitis (study under dermatological control)
This study is conducted as a single-center, open-labeled study in Latin America. A total of 59 subjects are enrolled in the study. Assessments are performed at Day 1, Day 8 and Day 29.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
59
Emollient cream, applied once daily to face and body for a period of 4 weeks.
Bárbara NAHUM
Rio de Janeiro, Rio de Janeiro, Brazil
Atopic Dermatitis Severity by the investigator- SCORAD (SCORing Atopic Dermatitis)
Evolution of the SCORAD assessed by the Investigator at each visit
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)
Atopic Dermatitis Severity by the investigator- L-SCORAD (Local SCORing Atopic Dermatitis)
Evolution of the Local-SCORAD assessed by the Investigator at each visit on a target area (= area most representative of Atopic Dermatitis severity of the entire body)
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)
Atopic Dermatitis Severity by the subject- PO-SCORAD (Patient-Oriented SCORing Atopic Dermatitis)
Evolution of the PO-SCORAD self-assessed by the subject or parent's)/legal representative at each visit
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Discomfort sensations
Evolution of discomfort self-assessed by the subject or parent's)/legal representative using a Numerical Rating Scale (NRS, 0-10; 0 = no symptom, 10 = worst imaginable symptom)
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Dermatological tolerance of the tested product
Tolerance assessed by the Investigator at each study visit. The results will take into account the clinical signs observed by the investigators and the signs reported by the subject based on a 5-point scale (From 1 = Excellent tolerance to 5 = Bad tolerance)
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Quality of life questionnaire
Quality of life self-assessed by the subject or parent's)/legal representative by completing the Dermatology Life Quality Index (DLQI) or Children's Dermatology Life Quality Index (CDLQI) or Infant Dermatology Quality of Life Index (IDQOL) questionnaire according to the subject age
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Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Atopic dermatitis disease control
Atopic dermatitis disease control self-assessed by the subject or parent's)/legal representative by completing the ADCT (Atopic Dermatitis Control Tool) questionnaire. The outcome measure assesses AD control over the past week, including symptom frequency and impact on daily activities. Total score ranges from 0 to 24; a score ≥ 7 indicates inadequately controlled AD.
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Acceptability Questionnaire assessment
Acceptability questionnaire regarding the use of the product completed by the subject/legal representative.
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Post-Inflammatory Hyper- or Hypo-pigmentation Intensity on a Target Lesion
Evolution of one selected post inflammatory hyperpigmentation area AND/OR one selected post inflammatory hypopigmentation area induced by atopic dermatitis assessed by the dermatologist using a 4-point lesion intensity scale (0=none to 3=severe).
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Extent of Dyschromic Areas
Evolution of the extent of skin areas affected by post-inflammatory dyschromia (hyper- or hypopigmentation) assessed by the investigator using the SCORAD parameter A methodology (rule of nines, scale 0 to 100), adapted to dyschromic lesions.
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)