Loading search results

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.

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
+36 more secondary outcomes

Interventions

Cosmetic studyOther

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age3 Years+

Sexall

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

Sampling MethodNon-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;

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Interventions

Emollients

Condition Hierarchy (Ancestors)

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

CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (41)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (41)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations