Clinical trial NCT05786976: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Diathesis
Eczema-Prone Skin
Lead sponsor: Bionorica SE
Sponsor class: INDUSTRY
First posted: 2023-03-28
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intra-individual comparison
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Mean change from baseline in transepidermal water loss (g/m2h)
timeFrame: 29 days
measure: Mean change from baseline in skin redness by Chromameter
timeFrame: 29 days
measure: Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.])
timeFrame: 29 days
measure: Changes from baseline in local SCORAD (Scoring Atopic Dermatitis, min=0, max=3; 3=worse outcome) in children
timeFrame: 29 days
measure: Changes from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist
timeFrame: 29 days
measure: Changes from baseline in POEM (Patient-oriented eczema measure, min=0, max=28; 28=worse outcome)
timeFrame: 29 days
Secondary outcomes:
measure: Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome)
timeFrame: 29 days
measure: Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
timeFrame: Day 1, after first application
measure: Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
timeFrame: 8 days
measure: Evaluation of products traits via questionnaire (20 questions with different answers, no scales)
timeFrame: 29 days
measure: Safety of BNO 3732 measured by reported Adverse Events
timeFrame: until day 29
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: SGS proderm GmbH
Study officials:
affiliation: proDERM GmbH
name: Sabrina Laing, Dr.
role: PRINCIPAL_INVESTIGATOR
References: