CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05783453
Study type	Observational
Source	Cosmetique Active International
Contact
Status	Completed
Phase
Start date	December 20, 2021
Completion date	July 22, 2022

View Details

See also
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