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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
Secondary objective
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic study | Other | LIPIKAR BAUME LIGHT AP+M
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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children and adult subjects with mild atopic dermatitis
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| Name | Affiliation | Role |
|---|---|---|
| Daniele Miranda, MD | CIDP Brasil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIDP | Rio de Janeiro | 20231-048 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37575149 | Derived | Cestari S, Correia P, Kerob D. Emollients "Plus" are Beneficial in Both the Short and Long Term in Mild Atopic Dermatitis. Clin Cosmet Investig Dermatol. 2023 Aug 8;16:2093-2102. doi: 10.2147/CCID.S417622. eCollection 2023. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D004643 | Emollients |
| ID | Term |
|---|---|
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |