Azathioprine Versus Corticosteroids in Parthenium Dermatitis
Condition: Parthenium Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

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.
    

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.
    

Intervention name(s): azathioprine and corticosteroids for Parthenium dermatitis
Intervention type(s): Drug
Intervention MeSH terms: Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Parthenium dermatitis