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

A COMPARISON OF THE EFFICACY OF STEROID PATCH CONTAINING BETAMETHASONE17 ,21DIPROPIONATE TO TOPICAL BETAMETHASONE17 ,21DIPROPIONATE TO TREAT IN CHRONIC HAND ECZEMA

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220413003
Enrollment
56
Registered
2022-04-13
Start date
2022-05-24
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Mild to moderate chronic hand eczema Chronic hand eczema, Mild to moderate severity

Interventions

Participants will apply transdermal patch containing betamethasone17 ,21dipropionate over all lesions for 8 hours once a day during bedtime.,Participants will apply topical betamethasone17 ,21dipropio
Active Comparator Drug,Active Comparator Drug
Participants using with transdermal patch,Participants using with topical steroid

Sponsors

Faculty of Medicine, Srinakharinwirot University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactSirinan Thaitirarot

Skin Center Srinakharinwirot University

sirinan.ttr@gmail.com0893619562

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026