Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With Atopic Eczema (AtoCare-OS)

March 28, 2023 updated by: Bionorica SE

Assessment of the Short- and Long-Term Skin Efficacy and Tolerability of a Cosmetic Product Combination of Body Lotion and Intensive Care Over 3 Months in Subjects With Atopic Eczema

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schenefeld, Germany, 22869
        • SGS proderm GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Body Lotion BNO 3732 + Intensive Care BNO 3731
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85
Time Frame: 85 days of treatment
85 days of treatment
Change from baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM, (min = 0, max = 3; 3 = worst outcome) to Day 29, Day 57 and Day 85
Time Frame: 85 days of treatment
85 days of treatment
Change from baseline in Recap of atopic eczema (RECAP, min = 0, max = 4; 4 = worst outcome) to Day 29, Day 57 and Day 85
Time Frame: 85 days of treatment
85 days of treatment
Change from baseline in Dermatology Life Quality Index (DLQI, 10 closed questions with varying scales) to Day 29, Day 57 and Day 85
Time Frame: 85 days of treatment
85 days of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (no scales) to Day 29, Day 57 and Day 85
Time Frame: 85 days of treatment
85 days of treatment
Evaluation of product traits via questionnaire (7 questions with different answers, no scales) on day 1 and after 29, 57, 85 days
Time Frame: 85 days of treatment
85 days of treatment
Sub-group: mean change from baseline in transepidermal water loss (g/m2h), Lipid contents (ng/133mm²) and Morphological analysis (length of lipid lamellae, nm/1.000nm²) to Day 85
Time Frame: 85 days of treatment
85 days of treatment
Safety of BNO 3732 and BNO 3731 measured by reported Adverse Events to Day 85
Time Frame: 85 days of treatment
85 days of treatment
Subject diary (frequency of flare-ups, required physician visits, required drug administration/use of cortisone, well-being)
Time Frame: 85 days of treatment
85 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bionorica SE

Investigators

  • Principal Investigator: Katrin Unbereit, Dr., proDERM GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Anticipated)

March 30, 2023

Study Completion (Anticipated)

March 30, 2023

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AtoCare-OS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Clinical Trials on Body Lotion and Intensive Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe