Paraffin Bath Therapy for Chronic Hand Eczema

Study Overview
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Brief Summary
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Objective: Chronic Hand eczema (CHE) is a common inflammatory skin disease has a major medical psychological and socio-economic implications that affect quality of life (QoL)and work ability. This study, the first randomized controlled trial that will be conducted to evaluate the effect of paraffin bath therapy (PBT) in the treatment of CHE.

Detailed Description
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Design: The study design is a randomized controlled trial with measures at pre-and post-intervention. Subjects: Sixty patients with moderate to severe Chronic Hand eczema (CHE) will participate in the study. They will be classified randomly into two groups of equal number; paraffin group and the control group. Interventions: Paraffin group will receive Paraffin bath therapy for 5 days per week for 12 weeks in addition to routine skin care program while the control group will receive routine skin care program. Outcome Measures: Objective SCORing Atopic Dermatitis, subjective item score and dermatology life quality index (DLQI) will be assessed before, at 6th week and at 12th week of treatment.

Official Title
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Beneficial Effects of Paraffin Bath Therapy as Additional Treatment of Chronic Hand Eczema: A Randomized Controlled Trial

Conditions
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Eczema

Intervention / Treatment
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* Other: Paraffin baths therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 20-40 years Time elapsed from the beginning of the disease ; more than three months according to the Guideline of the German Dermatological Society Exclusion Criteria: active eczematous lesions on other parts of the body; malignant or premalignant skin tumors

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sixty patients with moderate to severe Chronic Hand eczema (CHE) will participate in the study. They will be classified randomly into two groups of equal number; paraffin group and the control group. Interventions: Paraffin group will receive Paraffin Therapy for 5 days per week for 12 weeks in addition to routine skin care program while the control group will received routine skin care program
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paraffin baths therapy (PBT) :group A<br>Patients in treatment group will receive paraffin wax baths for five days per week for 12 weeks. | Other: Paraffin baths therapy<br>* Patients in treatment group will receive paraffin wax baths for five days per week for 12 weeks. Prepare the paraffin device and blocks of paraffin wax. Put the paraffin wax blocks inside the tank and set the thermostat 35 to 40◦C. Melting paraffin was taken from 90 to 120 minutes. Adjust the suitable temperature for each patient before immersion of patient's hand. Submerge patient's hand completely for three to four seconds then withdraw it<br>|
| No Intervention: Control group (B)<br>receive routine skin care program ; lifestyle change, emollients and moisturizers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD (SCORing Atopic Dermatitis | is the most widely clinical tool for assessing the severity (i.e. extent, intensity) of atopic dermatitis as objectively as possible.20 It consists of six objective items (erythema, oedema/papules, effect of scratching, oozing/crust formation, lichenification, and dryness), and two subjective symptoms (itch and sleeplessness), the maximum score is 103 points | Change from Baseline at SCORAD score at 6th week and at 12th weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology life quality index (DLQI) | DLQI consists of ten questions describe symptoms, feelings, leisure activities, work or school activities, personal relationships and treatment | Change from Baseline at 6th week and at 12th weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paraffin bath therapy, Hand Eczema, SCORAD, DLQI, Itching