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

ACO Hud Nordic

Status and phase: Completed; Phase 4

Conditions: Hand Eczema

Treatments: Drug: betamethasone valerate; Drug: Urea

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00576550

SMR-1588

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 4 patient groups

1:1

Experimental group

Description:

Part 1 of the study (maintenance part)

Treatment:

Drug: Urea

1:2

No Intervention group

Description:

Part 1 of the study (maintenance part)

2:1

Experimental group

Description:

Part 2 of the study (eczema part)

Treatment:

Drug: betamethasone valerate

Drug: betamethasone valerate

2:2

Active Comparator group

Description:

Part 2 of the study (eczema part)

Treatment:

Drug: betamethasone valerate

Drug: betamethasone valerate