Back to resultsAssessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis
Primary Purpose
Atopic Diathesis, Eczema-Prone Skin
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Lotion BNO 3732
Body Lotion Benchmark product
Sponsored by
About this trial
This is an interventional other trial for Atopic Diathesis
Eligibility Criteria
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
Sites / Locations
- SGS proderm GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lotion BNO 3732 for topical care
Body Lotion Benchmark product for topical care
Arm Description
Outcomes
Primary Outcome Measures
Mean change from baseline in transepidermal water loss (g/m2h)
Mean change from baseline in skin redness by Chromameter
Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.])
Changes from baseline in local SCORAD (Scoring Atopic Dermatitis, min=0, max=3; 3=worse outcome) in children
Changes from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist
Changes from baseline in POEM (Patient-oriented eczema measure, min=0, max=28; 28=worse outcome)
Secondary Outcome Measures
Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome)
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Safety of BNO 3732 measured by reported Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05786976
Brief Title
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis
Official Title
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionorica SE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Diathesis, Eczema-Prone Skin
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intra-individual comparison
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lotion BNO 3732 for topical care
Arm Type
Experimental
Arm Title
Body Lotion Benchmark product for topical care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Lotion BNO 3732
Intervention Description
Crem body lotion twice daily
Intervention Type
Other
Intervention Name(s)
Body Lotion Benchmark product
Intervention Description
Crem body lotion twice daily
Primary Outcome Measure Information:
Title
Mean change from baseline in transepidermal water loss (g/m2h)
Time Frame
29 days
Title
Mean change from baseline in skin redness by Chromameter
Time Frame
29 days
Title
Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.])
Time Frame
29 days
Title
Changes from baseline in local SCORAD (Scoring Atopic Dermatitis, min=0, max=3; 3=worse outcome) in children
Time Frame
29 days
Title
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
Title
Changes from baseline in POEM (Patient-oriented eczema measure, min=0, max=28; 28=worse outcome)
Time Frame
29 days
Secondary Outcome Measure Information:
Title
Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome)
Time Frame
29 days
Title
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Time Frame
Day 1, after first application
Title
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Time Frame
8 days
Title
Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
Time Frame
29 days
Title
Safety of BNO 3732 measured by reported Adverse Events
Time Frame
until day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabrina Laing, Dr.
Organizational Affiliation
proDERM GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
SGS proderm GmbH
City
Schenefeld
ZIP/Postal Code
22869
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis
We'll reach out to this number within 24 hrs