CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS: REDUCTION OF CRISES AND MAINTENANCE OF TREATMENT. STUDY UNDER NORMAL CONDITIONS OF USE AND DERMATOLOGICAL SUPERVISION

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Cosmetic study

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20231-048
    • CIDP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children and adult subjects with mild atopic dermatitis

Description

Inclusion Criteria:

• Women or men, from 3 years old, being 50% children (≥3 years old ≤ 11 years and 11 months) and 50% adults;
• All phototypes (a good balance between the phototypes is not mandatory, but all phototypes should be included);
• Diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features);
• Subject with mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion < 25);
• Subjects that have an unchanged AD routine for at least 3 months, including to systematic use of topical or systemic antihistamines, topical or systemic corticoid, cyclosporin A and other immunosuppressant.
• Subject able to use the study product at least once a day during all study.
• Subject agreeing not to change their lifestyle during the study period (overbathing, being exposed to intense stress as change job, do a fast diet to loose weight…);
• Subject agreeing to use only the study product and no other topical treatment for the duration of the study (usual topical or oral treatment for AD is allowed);
• Subject capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations;
• Subject available to follow the study;
• Subject agreeing to participate and having signed the informed consent;
• Subject available to be contacted by phone throughout the study.

Exclusion Criteria:

• Breastfeeding, pregnant;
• Subject presenting with another dermatological condition that could interfere with clinical evaluation;
• Subject presenting a previous history of allergy to cosmetic products;
• Subject having received any systemic treatment, including PUVA therapy for atopic dermatitis in the month prior to Day 0;
• Subject having received phototherapy within 2 weeks before the first visit;
• Subject who intend to excessively expose themselves to the sun during the study;
• Subject known allergy to any component of the tested product (subjects will be asked if they have allergies to any ingredients and will be checked in the list if it is contained in the IP);
• Subject who have used any experimental treatment within 2 weeks before the first visit;
• Subject not presenting with the conditions needed to comply with the protocol;
• Subject unable to give their informed consent;
• Subject not available to follow the study in its entirety.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Study Director: Daniele Miranda, MD, CIDP Brasil

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: atopic dermatitis, eczema, emollient
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Dermatologic Agents; Emollients
• Other Study ID Numbers: 2122CBCL002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No