CIDP
Rio de Janeiro, 20231-048, Brazil
NCT Number: NCT05783453
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.
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Notify Me3 year and older
All sexes
Observational
Rio de Janeiro, 20231-048, Brazil
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LIPIKAR BAUME LIGHT AP+M
Other names: Emollient
Time frame: baseline
Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Time frame: Day 14
Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Time frame: Day 28
Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Time frame: Day 84
Maintenance of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Time frame: Day 168
Maintenance of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Time frame: Baseline
Evaluation of flares quantity and severity on a scale 0=none to 4=severe
Time frame: Day 84
Evaluation of flares quantity and severity on a scale 0=none to 4=severe
Time frame: Day 168
Evaluation of flares quantity and severity on a scale 0=none to 4=severe
Time frame: Baseline
Improvement on a scale 0=none to 4=severe
Time frame: Day 14
Improvement on a scale 0=none to 4=severe
Time frame: Day 28
Improvement on a scale 0=none to 4=severe
Time frame: Day 84
Improvement on a scale 0=none to 4=severe
Time frame: Day 156
Improvement ona scale0=none to 4=severe
Time frame: Day 14
Subject questionnaire
Time frame: Day 28
Subject questionnaire
Time frame: Day 84
Subject questionnaire
Time frame: Day 156
Subject questionnaire
Time frame: Baseline
Transepidermal water loss using tewameter
Time frame: Day 14
Transepidermal water loss using tewameter
Time frame: Day 28
Transepidermal water loss using tewameter
Time frame: Day 84
Transepidermal water loss using tewameter
Time frame: Day 156
Transepidermal water loss using tewameter
Time frame: Baseline
Moisturising effect using corneometer
Time frame: Day 14
Moisturising effect using corneometer
Time frame: Day 28
Moisturising effect using corneometer
Time frame: Day 84
Moisturising effect using corneometer
Time frame: Day 156
Moisturising effect using corneometer
Time frame: Baseline
scale 0=none to 4=severe
Time frame: Day 14
scale 0=none to 4=severe
Time frame: Day 28
scale 0=none to 4=severe
Time frame: Day 84
scale 0=none to 4=severe
Time frame: Day 156
scale 0=none to 4=severe
Time frame: Baseline
DLQI (Dermatology Life Quality Index) questionnaire
Time frame: Day 14
DLQI (Dermatology Life Quality Index) questionnaire
Time frame: Day 28
DLQI (Dermatology Life Quality Index) questionnaire
Time frame: Day 84
DLQI (Dermatology Life Quality Index) questionnaire
Time frame: Day 156
DLQI (Dermatology Life Quality Index) questionnaire
Time frame: Day 14
reporting of events
Time frame: Day 28
reporting of events
Time frame: Day 84
reporting of events
Time frame: Day 156
reporting of events
Time frame: Baseline
scale
Time frame: Day 14
scale
Time frame: Day 28
scale
Time frame: Day 84
scale
Time frame: Day 156
scale
Cosmetique Active International
Industry
CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS: REDUCTION OF CRISES AND MAINTENANCE OF TREATMENT. STUDY UNDER NORMAL CONDITIONS OF USE AND DERMATOLOGICAL SUPERVISION
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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