Paraffin Bath Therapy for Chronic Hand Eczema

Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510961
• Other study ID #: Paraffin Hand Eczema
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: January 25, 2020

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 25, 2020
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Eczema

Intervention

Other:
• Paraffin 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

Locations

Country	Name	City	State
Saudi Arabia	Zizi Mohammed Ibrahim Ali	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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