Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With Atopic Eczema

NCT ID: NCT05790083

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2023-03-30

Brief Summary

The aim of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. Efficacy is assessed by instrumental measurements of skin condition (sub-panel), clinical examinations, and questionnaires.

Detailed Description

The objective of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use.

For efficacy and tolerability evaluation, an objective dermatological assessment will be performed, in addition to assessing efficacy, the severity of atopic eczema will be assessed using the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). Further, the effect of the test product combination on symptom severity, disease control (recap of atopic eczema (RECAP)), quality of life and well-being will be evaluated by the subjects or the subjects' parents/ legal guardians. The subjects or the subjects' parents/ legal guardians will also document the frequency of flare-ups, required physician visits and the use of cortisone administration as well as their/ their child's well-being in a diary.

Additionally, the influence of the test product combination on the skin barrier will be assessed in a sub-panel with dry legs by measuring the transepidermal water loss by Aquaflux and by sampling of biological material for analysis of skin lipids and corneocyte maturity before and after 3 months of product use.

Conditions

Atopic Dermatitis; Eczema-Prone Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Body Lotion BNO 3732 + Intensive Care BNO 3731

Group Type: EXPERIMENTAL

Body Lotion and Intensive Care

Intervention Type: OTHER

Body Lotion, applied twice daily on whole body, for 3 months. Intensive Care, applied as needed on affected body areas.

Interventions

Body Lotion and Intensive Care

Body Lotion, applied twice daily on whole body, for 3 months. Intensive Care, applied as needed on affected body areas.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Written Informed Consent of the subject to participate in the study, or, for underaged subjects of the parents/ legal guardians to let their child participate in the study
• Willingness to actively participate in the study and to come to the scheduled visits or, for underaged subjects, willingness of the parents/ legal guardians to actively support their child's participation in the study and to come to the scheduled visits with their child
• Female and/or male
• Children from 2 to 17 years of age and adult subjects between 18 and 75 years of age
• Eczema-prone skin and atopic dermatitis, diagnosed by the dermatologist

Exclusion Criteria

• Female subjects (only of childbearing age): Pregnancy or lactation
• Drug addicts, alcoholics (only adults)
• AIDS, HIV-positive or infectious hepatitis
• Conditions which exclude a participation or might influence the test reaction/evaluation
• Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
• Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
• Insulin-dependent diabetes mellitus
• One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
• Documented allergies to cosmetic products and/or ingredients, skin care and/ or skin cleansing products as well as to ingredients of the test products
• Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
• Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids, cyclosporine, dupilumab) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
• Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac, ibuprofen), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study
• Any topical medicinal products (e.g. topical corticosteroids, calcineurin inhibitors) at the test area within the last 5 days prior to the start of the study
• Any topical medication at the test area throughout the entire course of the study (except the medication normally used for treatment of atopic eczema)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bionorica SE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katrin Unbereit, Dr.

Role: PRINCIPAL_INVESTIGATOR

proDERM GmbH

Locations

SGS proderm GmbH

Schenefeld, , Germany

Countries

Germany

Other Identifiers

AtoCare-OS

Identifier Type: -

Identifier Source: org_study_id