Azathioprine Versus Corticosteroids in Parthenium Dermatitis

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00189397
First received: September 12, 2005
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Parthenium Dermatitis
Drug: azathioprine and corticosteroids for Parthenium dermatitis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Azathioprine Versus Corticosteroids for the Treatment of Parthenium Dermatitis

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Clinical remission and side effects

Secondary Outcome Measures:
  • Duration of remission

Study Start Date: February 2003
Study Completion Date: January 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00189397

Locations
India
Department of Dermatology, AIIMS
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Kaushal K Verma, MD All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189397     History of Changes
Other Study ID Numbers: PD 358, I 358
Study First Received: September 12, 2005
Last Updated: May 6, 2008
Health Authority: India: Indian Council of Medical Research

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Parthenium dermatitis

Additional relevant MeSH terms:
Dermatitis
Skin Diseases
Azathioprine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014