Azathioprine Versus Corticosteroids in Parthenium Dermatitis

Parthenium Dermatitis Clinical Trial

Official title:

Azathioprine Versus Corticosteroids for the Treatment of Parthenium Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189397
• Other study ID #: PD 358
• Secondary ID: I 358
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 6, 2008
• Start date: February 2003
• Est. completion date: January 2006

Study information

• Verified date: May 2008
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

The dermatitis caused by the substances which come in contact with the skin is known as contact dermatitis. When such a reaction is caused by the agents suspended in the air, it is called air-borne contact dermatitis (ABCD). Parthenium hysterophorus at present is the commonest cause of ABCD in India though in some cases other plants have also been found to cause ABCD. Parthenium dermatitis is one of the major health problems in dermatology in our country. Though it has very little mortality, the disease normally continues to persist with variable remissions and relapses causing great distress and morbidity. Corticosteroids, topical and systemic have been the mainstay of the treatment so far. Therefore, the patients with ABCD who have to take corticosteroids for long periods of time tend to develop severe and sometimes irreversible side effects of the therapy. Azathioprine is an immunosuppressive drug which acts by inhibiting the T lymphocytes. In our previous studies we have been able to induce remissions in these patients with azathioprine used as daily as well as monthly bolus dose, without having to use systemic corticosteroids. The side effect with azathioprine in these studies were almost absent.

We have therefore planned to study the therapeutic efficacy of azathioprine weekly pulse doses versus daily azathioprine in achieving remissions in patients having Parthenium dermatitis and to monitor the side effects of both the regimens.

Description:

Detailed research plan Clinical evaluation About 60 clinically diagnosed adult patients having Parthenium dermatitis will be taken up for the study. Pregnant females and lactating mothers will be excluded. All the patients will be patch tested with the standardised aqueous extract of Parthenium hysterophorus to confirm the diagnosis and those showing positive patch test reactions to standardised extract will be tested further with serial dilutions of the antigens to determine the titre of contact hypersensitivity (TCH).20 Antibodies do not have any role in this disease therefore the estimation of immunoglobulins will not be done. The diagnosis will be done by patch test. It will be a randomised, clinically study where the patients will be randomly treated with azathioprine 300 mg per week or azathioprine 100 mg a day orally along with topical clobetasol propionate 0.05% w/w and oral cetirizine hydrochloride 10 mg daily for symptomatic relief. No other drugs including the medicines of alternate system will be given for the dermatitis. Clinical evaluation of the patients will be undertaken every four weeks. This will be continued for six months. After 6 months the treatment will be stopped and the patients will be followed up for another 6 months. The graphic record of the disease activity and the treatment will be maintained. In addition, each patient will be evaluated for the side effects of these regimens clinically as well as by the laboratory parameters as per the proforma enclosed, especially haemoglobin, total blood count, differential count, platelets, serum bilirubin, serum alkaline phosphate, serum transaminases, serum electrolytes, serum creatinine, blood urea, blood sugar, urine routine and microscopy and stool examination for occult blood. These tests will be carried out before starting the therapy and then repeated every month during the follow up period. Chest X-ray electrocardiogram and TCH will also be done before the therapy and then at six months unless otherwise required. At the end of the study period, a final evaluation based on the change in severity of the dermatitis, changes in the titre of contact hypersensitivity and the side effects of the drugs will be made. Statistical analysis using chi-square test will be done.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2006
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• All adult patients having ABCD, as shown by the clinical manifestations and positive patch tests with Parthenium, who are willing to participate in the study.

Exclusion Criteria:

• Patients below the age of 18 years

• Pregnant and lactating women.

• Patients whose baseline investigations reveal hematological abnormalities or abnormalities of liver or renal function.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Parthenium Dermatitis

Intervention

Drug:
• azathioprine and corticosteroids for Parthenium dermatitis

Locations

Country	Name	City	State
India	Department of Dermatology, AIIMS	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission and side effects
Secondary	Duration of remission