Efficacy Evaluation and Cutaneous Acceptability of the Lipikar Med Product on Subjects With Atopic Dermatitis

NCT05531188 | Completed

• 1 other identifier: LRP 20003 LIPIKAR
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we will test the tolerance of a topical product and its efficacy in reducing the atopy crisis duration and severity. The product will be tested alone, in children and adults with acute mild to moderate AD i.e as an alternative to alternative treatments, over 6 weeks.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Evolution in Investigator Global Assessment (IGA)

  The dermatologist uses the IGA score to evaluate the overall appearance of the lesions and evaluation of time of resolution of the studied lesion. A decrease is expected in the number and percentage of subjects who evolve from Clear to almost Clear (IGA 0-1) at each visit

  Day 0, Day 7, Day 14, Day 21 and Day 42

• Evolution in score of atopic dermatitis

  The dermatologist uses the global local SCORAD score to evaluate the overall appearance of all the lesions. The following signs are recorded on all the application zones:erythema, oedema/papulation, oozing/crusting, excoriation, lichenification, xerosis. For each sign on the application zone: \- intensity will be reported using the following 4-point scale and their respective mean scores will be noted. A decrease in the global score is the expected result. The parameter results will be evaluated individually and must decrease

  Day 0, Day 7, Day 14, Day 21 and Day 42

Secondary Outcomes (13)

• Evolution in Patient Oriented SCORAD (PO-SCORAD)

  Day 0, Day 7, Day 14, Day 21, Day 28 and Day 42

• Evolution in Surface area affected

  Day 0, Day 7, Day 21 and Day 42

• Evolution in Clinical scoring of pain

  Day 0, Day 7, Day 14, Day 21, Day 28 and Day 42

• Evolution in Evolution in Patient Oriented Eczema Measure (POEM)

  Day 0, Day 7, Day 14, Day 21 and Day 42

• Evolution in Quality of life questionnaire (DLQI &CDLQI)

  Day 0, Day 7, Day 21 and Day 42

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study took place in Mauritius. Population comes from a database of subjects registered as suffering from DA. Further to facilitate recruitment, agents were appointed to look out for subjects presenting the required condition

You may qualify if:

• Sex: female and male; Age: children from 2 to 17 years old, adults from 18 to 75 years old; Phototype: all phototypes Subjects with atopic dermatitis lesions that does not exceed 400 cm2, the studied area must be of evaluable size; 50% of the subjects having atopic dermatitis lesion mainly on the face and neck; 50% of the subjects having atopic dermatitis lesion mainly on the body (folds, trunk limbs, etc.); Subject with mild to moderate atopic dermatitis, IGA 2 (75% of the subjects) to 3 (25% of the subjects); Locally on the lesional area (face/ neck or fold): IGA 2 to 3. Subject having given his/her free informed, written consent; Subject willing to adhere to the protocol and study procedures.

You may not qualify if:

• Subjects presenting symptoms of COVID - 19 (moderate fever, dry cough, and other symptoms as described by the World Health Organisation); Subjects with a temperature higher than 37.5°C; Subject having been tested positive for COVID-19 and without a medical certificate from the Government; For women: pregnant or nursing woman or woman planning to get pregnant during the study; Children less than two years old; Severe atopic dermatitis (IGA\>3); Presenting lichenification 1 or 2 for the 25% of subjects with IGA 3; Presenting with another dermatological condition that could interfere with clinical evaluation; Presenting with a previous history of allergy to cosmetic products; Current and past (last 2 weeks) systematic use of topical or systemic antihistamines, topical or systemic steroids, cyclosporin A and other immunosuppressant, naltrexone, paroxetin, fluvoxamine, amitriptylin;
• Wash-out treatment for prior or concomitant therapy:

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

Insight Research

Quatre Bornes, Mauritius

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin microbial flora

MeSH Terms

Conditions

Dermatitis, Atopic

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

Study Officials

• Aslham Doarika

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: September 7, 2022
• Study Start: March 1, 2021
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

MA (1)