Loading search results

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
+8 more secondary outcomes

Eligibility Criteria

Age2 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (13)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (13)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations