Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis

March 27, 2023 updated by: Bionorica SE
The aim of this study is to compare the efficacy and tolerability of a cosmetic product to one that is already available on the market (benchmark product). Efficacy is assessed by instrumental measurements of skin condition, clinical examinations, and questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this exploratory study is to investigate the efficacy and tolerability of a cosmetic product on subjects with atopic dermatitis after 4 weeks of use in comparison to a benchmark product.

The efficacy will be evaluated via instrumental measurements of skin hydration by Corneometer, transepidermal water loss by Tewameter and erythema by Chromameter. Furthermore, the efficacy was evaluated by dermatological assessment using the local SCORing Atopic Dermatitis (SCORAD) rated by a dermatologist in the children, the dermatological assessment rated by a dermatologist (objective) and the dermatological assessment rated by adult subject (subjective) in the test areas, respectively.

Additionally, at the beginning and at the end of the study the Patient-Oriented Eczema Measure (POEM) will be evaluated by the subjects or the subjects' parents/legal guardians by questionnaires.

The SCORAD evaluation and the objective and subjective dermatological assessments will also be used for the tolerability assessment of the test products.

Study Type

Interventional

Enrollment (Actual)

44

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

6 months to 65 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 underage 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 underage 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 6 months to 14 years of age and adults between 18 and 65 years of age
  • Eczema-prone skin and atopic diathesis, diagnosed by the dermatologist

Exclusion Criteria:

  • Female subjects: pregnancy or lactation
  • Drug addicts, alcoholics
  • 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
  • Wounds, moles, tattoos, scars, excessive hair growth, etc. at the test area that could influence the investigation
  • Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) 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), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lotion BNO 3732 for topical care
Other: Lotion BNO 3732
Crem body lotion twice daily
Active Comparator: Body Lotion Benchmark product for topical care
Other: Body Lotion Benchmark product
Crem body lotion twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in transepidermal water loss (g/m2h)
Time Frame: 29 days
29 days
Mean change from baseline in skin redness by Chromameter
Time Frame: 29 days
29 days
Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.])
Time Frame: 29 days
29 days
Changes from baseline in local SCORAD (Scoring Atopic Dermatitis, min=0, max=3; 3=worse outcome) in children
Time Frame: 29 days
29 days
Changes from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist
Time Frame: 29 days
29 days
Changes from baseline in POEM (Patient-oriented eczema measure, min=0, max=28; 28=worse outcome)
Time Frame: 29 days
29 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome)
Time Frame: 29 days
29 days
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Time Frame: Day 1, after first application
Day 1, after first application
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Time Frame: 8 days
8 days
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Time Frame: 29 days
29 days
Safety of BNO 3732 measured by reported Adverse Events
Time Frame: until day 29
until day 29

Collaborators and Investigators

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

Sponsor

Bionorica SE

Investigators

  • Principal Investigator: Sabrina Laing, 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 11, 2022

Primary Completion (Actual)

February 9, 2022

Study Completion (Actual)

February 9, 2022

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSBL01-ICBD

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.

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