The efficacy of a transdermal hydrogel patch containing betamethasone dipropionate for treatment of chronic hand eczema: A single-blind, randomized and controlled trial

Phase 4

Completed

• Conditions: Mild to moderate chronic hand eczema; Chronic hand eczema, Mild to moderate severity

• Registration Number: TCTR20220413003
• Lead Sponsor: Faculty of Medicine, Srinakharinwirot University

Brief Summary

The transdermal corticosteroid patch group demonstrated its safety and effectiveness, showing comparability to topical corticosteroids after 8 weeks of application. The patch's sustained-release features, when combined with once-daily application, have potential to enhance patient satisfaction and encourage better treatment adherence.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-13
• Study Completion: 2022-07-24
• Results First Posted: 2023-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Female or male patients aged over 18 years old.
2. Patients who have been diagnosed as mild to moderate chronic hand
eczema or have history of intermittent or persistent skin lesions such as eczematous or
vesicles on both hands for more than 3 consecutive months or relapse more than twice
a year with or without prior treatment.
3. Patients who have been assessed HECSI score as 0-27 and defined as
mild to moderate severity.
4. Patients who participate in the project voluntarily and sign the consent
form.
5. Patients who are able to follow-up examination in the 2nd, 4th, and 8th
week.

Exclusion Criteria

1. Patients who have current or active bacterial, fungal, or viral infection of
hands.
2. Patients who allergic to component of ingredients in topical steroid
ointment or patch using in this study as shown in Table 7 and 8.
3. Female patients who are pregnant, lactating or planning to become
pregnant during the study period.
4. Patients who have history of treatment with topical corticosteroids or
topical calcineurin inhibitors within 2 weeks before and during this study.
5.Patients who have history of treatment with systemic corticosteroids,
immunosuppressant such as cyclosporin, azathioprine, mycophenolate mofetil, and
phototherapy within 4 weeks before and during this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of transdermal patches containing 0.05%betamethasone17 ,21dipropionate in treatment of patients with chronic hand eczema. 2nd, 4th, and 8th week after using transdermal patch The Hand Eczema Severity Index (HECSI) score

Secondary Outcome Measures

Name	Time	Method
Efficacy of transdermal patches containing 0.05%betamethasone17 ,21dipropionate in treatment of patients with chronic hand eczema. Week 0 and 8th Physician Global Assessment (PGA) / All participants assess a development of the disease by changing score before to after procedure by themselves and physicians.,Adverse effects Every visits after start using transdermal patch Severity and duration of possible adverse effects related to treatment by transdermal patch, for examples erythema, burning, stinging etc.,Patient's compliance Week 2nd, 4th, and 8th after using transdermal patches Obtained from their logbooks,Satisfaction Week 8th after using transdermal patches Assessed from questionaire, Quality of life of patient by Dermatology Life Quality Index (DLQI) Week 0 and week 8th DLQI questionnaires