Paraffin Bath Therapy for Chronic Hand Eczema

NCT04510961 | Completed DMC

• 1 other identifier: Paraffin Hand Eczema
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Eczema

Keywords

Paraffin bath therapy, Hand Eczema, SCORAD, DLQI, Itching

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dermatology life quality index (DLQI)

  Change from Baseline at 6th week and at 12th weeks of treatment

Study Arms (2)

Paraffin baths therapy (PBT) :group A

ACTIVE COMPARATOR

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

Other: Paraffin baths therapy

Control group (B)

NO INTERVENTION

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

Interventions

Paraffin baths therapy 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

Paraffin baths therapy (PBT) :group A

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• active eczematous lesions on other parts of the body;
• malignant or premalignant skin tumors

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Zizi Mohammed Ibrahim Ali

Riyadh, 2136, Saudi Arabia

Location

MeSH Terms

Conditions

Eczema; Pruritus

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROF

Model Details: 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

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 12, 2020
• Study Start: January 10, 2019
• Primary Completion: November 12, 2019
• Study Completion: January 25, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

SA (1)