CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

Atopic Dermatitis Clinical Trial

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

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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