The primary objective of this study is to compare the therapeutical effect on atopic dermatitis of a standard used emollient (Unguentum leniens FNA) compared to a skin barrier repair cream (Dermalex Eczema), assessed by clinical and subjective…
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The primary outcome parameter in this study is transepidermal water loss (TEWL)
as an effect parameter for the skin barrier function
Erythema (skin redness) for the extent of skin inflammation
Secondary outcome
Change of severity of atopic dermatitis
Skin hydration
Change in itching
The amount of used cream/ointments (per day and total)
Experiences of the subjects on different ointments and effect on skin / eczema
symptoms.
Background summary
Atopic eczema ( AD) is a chronic and relapsing inflammatory skin disorder with
a wide spectrum of clinical presentations and combinations of symptoms. Skin
barrier dysfunction, which can be inherited or acquired, is a major hallmark of
AD, allowing for enhanced allergen and microbial penetration across the skin.
A defective skin barrier in AD exists even in nonlesional skin and is
characterized by increased transepidermal water loss (TEWL) as well as enhanced
percutaneous penetration of chemicals.
Current treatment of AD is the administration of topical corticosteroids or
immunosuppressive ointments to counter the immunological reaction and to
control flares. However, prolonged use of these treatments can induce
side-effects on long-term, stressing the need to develop new treatment
applications. Therapeutic intervention in AD should be aimed at both restoring
skin barrier function and reducing inflammation in the entire integument in
general and in AD lesions in particular, as impaired skin barrier function is
present in lesional as well as clinically uninvolved skin. Emollients have been
shown to restore skin barrier function and their frequent and generous use is
an essential part of the treatment regimen of AD. The investigated skin barrier
repair cream (Dermalex Eczema) contains magnesium salt and ceramides, both
known to influence skin barrier and inflammation. Clinical efficacy data for
these skin barrier repair creams are limited
Study objective
The primary objective of this study is to compare the therapeutical effect on
atopic dermatitis of a standard used emollient (Unguentum leniens FNA) compared
to a skin barrier repair cream (Dermalex Eczema), assessed by clinical and
subjective evaluation.
Study design
single-center, intra-individual comparison (right/left) intervention study
Study burden and risks
There are no health risks associated with this study.
All measurements are non-invasive with a sensor on the skin.
Patients with atopic dermatitis are used to use of daily ointments on their
skin, so 4 weeks use of 2 different ointments will not be an extra burden.This
study will provide information whether use of a protective skin barrier cream
is usefull in treatment of atopic dermatitis. In addition, if the protective
skin barrier cream is more efficient than a neutral ointment. Dermalex contains
no corticosteroids avoiding side effects caused by prolonged use of local
corticosteroids.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Clinically diagnosed atopic dermatitis
Mild to moderate atopic dermatitis
At least two symmetrical (i.e. left and right side of the body) skin sites with comparable atopic dermatitis severity
Age between 18 and 70 years
Exclusion criteria
- Other skin disease other than AD.
- Use of antihistamines prior to (72 hours) the study and/or expected use during the study.
- Use of antibiotics prior to (4 weeks) the study and/or expected use during the study.
- Use of inflammation suppressing medicines (e.g. corticosteroids, NSAIDs) prior to (4 weeks) the study and/or expected use during the study
- Use of systemic suppressing drugs (e.g. prednisone, methothrexate) prior to (4 weeks) the study and/or expected use during the study
-Severe disorders within the last 6 months before study (e.g. cancer, acute cardiac or circularity disorders, HIV, infectious hepatitis)
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL46576.018.13 |