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NCT Number: NCT04510961

Paraffin Bath Therapy for Chronic Hand Eczema

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.

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zizi Mohammed Ibrahim Ali

Riyadh, 2136, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. SCORAD ("SCORing Atopic Dermatitis

    Time frame: 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 outcomes

  1. Dermatology life quality index (DLQI)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 12, 2020
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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