A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00576550

Enrollment

Registered

2007-12-19

Start date

2007-10-31

Completion date

2008-05-31

Last updated

2008-10-13

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

Conditions

Hand Eczema

Keywords

Hand eczema, Prevention

Brief summary

The purpose of this study is to investigate whether a moisturizing cream can prevent hand eczema.Patients with previous hand eczema will be studied. In the second part of the study, it will be explored if a treatment regimen of a topical corticosteroid once daily is not inferior to treatment twice daily.

Interventions

DRUGUrea

Urea cream applied twice daily up to six months

DRUGbetamethasone valerate

Application once daily for two weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinically proven history of hand eczema * At inclusion controlled state of hand eczema (≤3 on Hand Eczema Extent Score, HEES) * Daily use of moisturising treatment * Either gender * Age 18 or above * Written Informed Consent

Exclusion criteria

* Possible allergy to ingredients in the study medications * At study start active psoriatic lesions or active atopic eczema lesions on the hands. Active bacterial, fungal or viral infection of the hands * Patients who are pregnant or breast-feeding, or who plan to become pregnant during the course of the study * Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy * Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse) * Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results * Inclusion in a study of an investigational drug within 60 days prior to start of treatment

Design outcomes

Primary

Measure	Time frame
Time to relapse of hand eczema	Up to 6 months

Secondary

Measure	Time frame
The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily	2 weeks

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026