Paraffin Bath Therapy for Chronic Hand Eczema

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04510961
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.5
• Patients Per Site Per Month: 4.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eczema	Other: Paraffin baths therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 programSixty 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: 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
• Primary Purpose: Treatment
• Official Title: Beneficial Effects of Paraffin Bath Therapy as Additional Treatment of Chronic Hand Eczema: A Randomized Controlled Trial
• Actual Study Start Date: Jan 10, 2019
• Actual Primary Completion Date: Nov 12, 2019
• Actual Study Completion Date: Jan 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Paraffin baths therapy (PBT) :group A Patients in treatment group will receive paraffin wax baths for five days per week for 12 weeks.	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
No Intervention: Control group (B) receive routine skin care program ; lifestyle change, emollients and moisturizers

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zizi Mohammed Ibrahim Ali	Riyadh		Saudi Arabia	2136

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ZIZI MOHAMMED IBRAHIM ALI, ASSOCIATE PROF, Cairo University
• ClinicalTrials.gov Identifier: NCT04510961
• Other Study ID Numbers: Paraffin Hand Eczema
• First Posted: Aug 12, 2020
• Last Update Posted: Aug 12, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ZIZI MOHAMMED IBRAHIM ALI, ASSOCIATE PROF, Cairo University: Paraffin bath therapy, Hand Eczema, SCORAD, DLQI, Itching
• Additional relevant MeSH terms: Eczema

Study Results

No Results Posted as of Aug 12, 2020