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

Bionorica

Status

Completed

Conditions

Eczema-Prone Skin

Atopic Diathesis

Treatments

Other: Lotion BNO 3732

Other: Body Lotion Benchmark product

Study type

Interventional

Funder types

Industry

Identifiers

NCT05786976

CSBL01-ICBD

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

6 months to 65 years old

Volunteers

Accepts Healthy Volunteers

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