Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05783453
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2023-03-13
Brief Title:
CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS
Sponsor:
Cosmetique Active International
Organization:
Cosmetique Active International
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 APM 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 APM 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
Primary objective
Evaluation of the efficacy of LIPIKAR BAUME LIGHT APM 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 APM 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None