Paraffin Bath Therapy for Chronic Hand Eczema

NCT ID: NCT04510961

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2020-01-25

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.

Conditions

Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Paraffin baths therapy (PBT) :group A

Patients in treatment group will receive paraffin wax baths for five days per week for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Paraffin baths therapy

Intervention Type: OTHER

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

Control group (B)

receive routine skin care program ; lifestyle change, emollients and moisturizers

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

ZIZI MOHAMMED IBRAHIM ALI

ASSOCIATE PROF

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zizi Mohammed Ibrahim Ali

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

Paraffin Hand Eczema

Identifier Type: -

Identifier Source: org_study_id