Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis
NCT ID: NCT05786976
Last Updated: 2023-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2022-01-11
2022-02-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Lotion BNO 3732 for topical care
Lotion BNO 3732
Crem body lotion twice daily
Body Lotion Benchmark product for topical care
Body Lotion Benchmark product
Crem body lotion twice daily
Interventions
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Lotion BNO 3732
Crem body lotion twice daily
Body Lotion Benchmark product
Crem body lotion twice daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
65 Years
ALL
Yes
Sponsors
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Bionorica SE
INDUSTRY
Responsible Party
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Principal Investigators
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Sabrina Laing, Dr.
Role: PRINCIPAL_INVESTIGATOR
proDERM GmbH
Locations
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SGS proderm GmbH
Schenefeld, , Germany
Countries
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Other Identifiers
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CSBL01-ICBD
Identifier Type: -
Identifier Source: org_study_id
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