Paraffin Bath Therapy for Chronic Hand Eczema

Not Applicable

Completed

• Conditions: Eczema
• Interventions: Other: Paraffin baths therapy

• Registration Number: NCT04510961
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2019-01-10
• Primary Completion: 2019-11-12
• Study Completion: 2020-01-25
• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Study First Posted: 2020-08-12
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paraffin baths therapy (PBT) :group A	Paraffin baths therapy	Patients in treatment group will receive paraffin wax baths for five days per week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zizi Mohammed Ibrahim Ali; 🇸🇦 Riyadh, Saudi Arabia