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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05783453
• Other study ID #: 2122CBCL002
• Status: Completed
• Start date: December 20, 2021
• Est. completion date: July 22, 2022

Study information

• Verified date: March 2023
• Source: Cosmetique Active International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 22, 2022
• Est. primary completion date: July 22, 2022
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Cosmetic study
LIPIKAR BAUME LIGHT AP+M Formula: 2039055 06 Aspect: Emulsion Batch nº: RAUO0063 Expiry date: 10/2022 Application area: Face and Body Application mode: Apply to face and body twice a day. Quantity of product to be applied: About 1 flask (400g) per month

Locations

Country	Name	City	State
Brazil	CIDP	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Flares	Evaluation of flares quantity and severity on a scale 0=none to 4=severe	Baseline
Secondary	Flares	Evaluation of flares quantity and severity on a scale 0=none to 4=severe	Day 84
Secondary	Flares	Evaluation of flares quantity and severity on a scale 0=none to 4=severe	Day 168
Secondary	Skin parameters	Improvement on a scale 0=none to 4=severe	Baseline
Secondary	Skin parameters	Improvement on a scale 0=none to 4=severe	Day 14
Secondary	Skin parameters	Improvement on a scale 0=none to 4=severe	Day 28
Secondary	Skin parameters	Improvement on a scale 0=none to 4=severe	Day 84
Secondary	Skin parameters	Improvement ona scale0=none to 4=severe	Day 156
Secondary	Product acceptability	Subject questionnaire	Day 14
Secondary	Product acceptability	Subject questionnaire	Day 28
Secondary	Product acceptability	Subject questionnaire	Day 84
Secondary	Product acceptability	Subject questionnaire	Day 156
Secondary	Skin hydration	Transepidermal water loss using tewameter	Baseline
Secondary	Skin hydration	Transepidermal water loss using tewameter	Day 14
Secondary	Skin hydration	Transepidermal water loss using tewameter	Day 28
Secondary	Skin hydration	Transepidermal water loss using tewameter	Day 84
Secondary	Skin hydration	Transepidermal water loss using tewameter	Day 156
Secondary	Skin moisturizing	Moisturising effect using corneometer	Baseline
Secondary	Skin moisturizing	Moisturising effect using corneometer	Day 14
Secondary	Skin moisturizing	Moisturising effect using corneometer	Day 28
Secondary	Skin moisturizing	Moisturising effect using corneometer	Day 84
Secondary	Skin moisturizing	Moisturising effect using corneometer	Day 156
Secondary	Folliculitis	scale 0=none to 4=severe	Baseline
Secondary	Folliculitis	scale 0=none to 4=severe	Day 14
Secondary	Folliculitis	scale 0=none to 4=severe	Day 28
Secondary	Folliculitis	scale 0=none to 4=severe	Day 84
Secondary	Folliculitis	scale 0=none to 4=severe	Day 156
Secondary	Evolution of Quality of life over time	DLQI (Dermatology Life Quality Index) questionnaire	Baseline
Secondary	Evolution of Quality of life over time	DLQI (Dermatology Life Quality Index) questionnaire	Day 14
Secondary	Evolution of Quality of life over time	DLQI (Dermatology Life Quality Index) questionnaire	Day 28
Secondary	Evolution of Quality of life over time	DLQI (Dermatology Life Quality Index) questionnaire	Day 84
Secondary	Evolution of Quality of life over time	DLQI (Dermatology Life Quality Index) questionnaire	Day 156
Secondary	local tolerance reporting	reporting of events	Day 14
Secondary	local tolerance reporting	reporting of events	Day 28
Secondary	local tolerance reporting	reporting of events	Day 84
Secondary	local tolerance reporting	reporting of events	Day 156
Secondary	Total body dryness	scale	Baseline
Secondary	Total body dryness	scale	Day 14
Secondary	Total body dryness	scale	Day 28
Secondary	Total body dryness	scale	Day 84
Secondary	Total body dryness	scale	Day 156