Eczema
Conditions
Keywords
Paraffin bath therapy, Hand Eczema, SCORAD, DLQI, Itching
Brief summary
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
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.
Interventions
OTHERParaffin baths therapy
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Measurements will be at three occasions: at randomization (T1), at 6th week (T2) and at 12th week (T3) of treatment. Evaluative procedures will be by a blind assessor
Intervention 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
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCORAD (SCORing Atopic Dermatitis | Change from Baseline at SCORAD score at 6th week and at 12th weeks of treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology life quality index (DLQI) | Change from Baseline at 6th week and at 12th weeks of treatment | DLQI consists of ten questions describe symptoms, feelings, leisure activities, work or school activities, personal relationships and treatment |
Countries
Saudi Arabia
Outcome results
None listed