CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

NCT05783453 | Completed

• 1 other identifier: 2122CBCL002
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis, eczema, emollient

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (41)

• Flares

  Baseline

• Flares

  Day 84

• Flares

  Day 168

• Skin parameters

  Baseline

• Skin parameters

  Day 14

Interventions

Cosmetic study OTHER

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

Also known as: Emollient

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

children and adult subjects with mild atopic dermatitis

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CIDP

Rio de Janeiro, 20231-048, Brazil

Location

Related Publications (1)

• Cestari S, Correia P, Kerob D. Emollients "Plus" are Beneficial in Both the Short and Long Term in Mild Atopic Dermatitis. Clin Cosmet Investig Dermatol. 2023 Aug 8;16:2093-2102. doi: 10.2147/CCID.S417622. eCollection 2023.

  PMID: 37575149 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Emollients

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Daniele Miranda, MD

  CIDP Brasil

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: December 20, 2021
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)