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Efficacy of Dermalex Eczema in atopic dermatitis patients

Efficacy of a skin barrier repair cream (Dermalex Eczema) in atopic dermatitis patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23349
Enrollment
100
Registered
2014-04-28
Start date
2014-05-06
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis

Interventions

Patients are instructed to apply Dermalex eczema cream, a standard emollient or a dermatocorticosetroid on one side of the body on atopic dermatitis lesions at least twice a day. The opposite side wil

Sponsors

AMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Clinically diagnosed atopic dermatitis - Mild to moderate atopic dermatitis, according to total SCORAD score (score <25 and <50 respectively) - Age between 18 and 70 years - Written informed consent - At least two symmetrical (i.e. left and right side of the body) skin sites with comparable AD severity (Measured in SCORAD-score)

Exclusion criteria

Exclusion criteria: - Extensive UV exposure in the last 14 days before study and/or expected during the study. - Other skin disease other than AD. - Use of antibiotics 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 outcomes

Primary

MeasureTime frame
Changed 22-may-2015: 1) Change in modified SCORAD in three and six weeks

Secondary

MeasureTime frame
- The amount of used cream/ointments (per day and total) - Change in cytokine levels, lipid profile, Trans epidermal water loss and PH after the different treatments. - presence of mutations on the Fillagrin-gene

Contacts

Public ContactS.A. Koppes

Coronel Institute of Occupational Health Academic Medical Center, AMC K0-116 Meibergdreef 9

s.a.koppes@amc.nl020 5665326

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)