Trials / Completed
CompletedNCT05786976
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Bionorica SE · Industry
- Sex
- All
- Age
- 6 Months – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Lotion BNO 3732 | Crem body lotion twice daily |
| OTHER | Body Lotion Benchmark product | Crem body lotion twice daily |
Timeline
- Start date
- 2022-01-11
- Primary completion
- 2022-02-09
- Completion
- 2022-02-09
- First posted
- 2023-03-28
- Last updated
- 2023-03-28
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05786976. Inclusion in this directory is not an endorsement.