Paraffin Bath Therapy for Chronic Hand Eczema
Primary Purpose
Eczema
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Paraffin baths therapy
Sponsored by
About this trial
This is an interventional treatment trial for Eczema focused on measuring Paraffin bath therapy, Hand Eczema, SCORAD, DLQI, Itching
Eligibility Criteria
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
Sites / Locations
- Zizi Mohammed Ibrahim Ali
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Paraffin baths therapy (PBT) :group A
Control group (B)
Arm Description
Patients in treatment group will receive paraffin wax baths for five days per week for 12 weeks.
receive routine skin care program ; lifestyle change, emollients and moisturizers
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Dermatology life quality index (DLQI)
DLQI consists of ten questions describe symptoms, feelings, leisure activities, work or school activities, personal relationships and treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04510961
Brief Title
Paraffin Bath Therapy for Chronic Hand Eczema
Official Title
Beneficial Effects of Paraffin Bath Therapy as Additional Treatment of Chronic Hand Eczema: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
January 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema
Keywords
Paraffin bath therapy, Hand Eczema, SCORAD, DLQI, Itching
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paraffin baths therapy (PBT) :group A
Arm Type
Active Comparator
Arm Description
Patients in treatment group will receive paraffin wax baths for five days per week for 12 weeks.
Arm Title
Control group (B)
Arm Type
No Intervention
Arm Description
receive routine skin care program ; lifestyle change, emollients and moisturizers
Intervention Type
Other
Intervention Name(s)
Paraffin baths therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
SCORAD ("SCORing Atopic Dermatitis
Description
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
Time Frame
Change from Baseline at SCORAD score at 6th week and at 12th weeks of treatment
Secondary Outcome Measure Information:
Title
Dermatology life quality index (DLQI)
Description
DLQI consists of ten questions describe symptoms, feelings, leisure activities, work or school activities, personal relationships and treatment
Time Frame
Change from Baseline at 6th week and at 12th weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Zizi Mohammed Ibrahim Ali
City
Riyadh
ZIP/Postal Code
2136
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Paraffin Bath Therapy for Chronic Hand Eczema
We'll reach out to this number within 24 hrs