Health Condition 1: null- Psoriasis
Conditions
Interventions
Intervention1: Clobetasol propionate 0.025%: 3.5 g Twice daily, topical for 28 days
Control Intervention1: Temovate E: 3.5 g Twice daily, topical for 28 days
Sponsors
Dr Reddys Laboratories
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female patients of at least 18 years of age, with a clinical diagnosis of moderate to severe psoriasis. 2.Patient must have moderate to severe psoriasis with at least 25% Body Surface Area (BSA) involvement at Screening and Baseline. The patient can have involvement on scalp, face, groin, axillae, and/or other intertriginous areas but the 25% should not include these areas. 3.Patients must have Psoriasis Global Assessment (PGA) score of at least 3 (moderate) or more at Screening and Baseline for the overall disease severity. 4.Patients whose results from the Screening cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response (screening visit ACTH test). 5.Female, if of child bearing potential - a.Must use efficacious and reliable method of contraception during the entire duration of the study {e.g. double barrier methods (e.g., condom and spermicide); IUD} or remain sexually inactive throughout the study. b.Must have a negative urine pregnancy test at Screening and Baseline (test must have a sensitivity of at least 25mIU/ml for hCG). c.Must be non-lactating. 6.Patients must demonstrate their willingness to participate in the study and comply with the study procedures and required visits. 7.Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. 8.Must be willing to authorize use and disclosure of protected health information collected for the study.
Exclusion criteria
Exclusion criteria: 1.Females who are pregnant or lactating or planning to become pregnant during the study period. 2.Patients with known hypersensitivity to clobetasol propionate or Temovate E® or any of the ingredients of the test drugs (see Section 4) 3.Patients who have used any corticosteroid within 4 weeks of the Screening visit. 4.Patients with known history of acute adrenal crisis, Addisons disease or decreased adrenal output, low pituitary function, or pituitary tumors. 5.Patient has a history of an adverse reaction to Cosyntropin (injection) or similar test reagents. 6.Patients whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas. 7.Patient has current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) 8.Patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy. 9.Patients taking or applying topical or systemic treatments likely to interfere with either psoriasis status or HPA axis function 10.Use of any of following by the patient: a.Currently receiving or has received any radiation therapy, anti-neoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug. b.Undergone treatment with any systemic or photo antipsoriatic therapy within 8 weeks of the first dose of study drug. c.Treated within 12 weeks (or five half lives whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis. d.Used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to Screening visit. 11.In the Investigators opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis 12.Patients with a serious and/or uncontrolled medical condition (chronic or active liver disease, renal impairment, heart disease, diabetes, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions or any other disease) that in the opinion of the investigator would interfere with the study or place the patient at unacceptable risk. 13.Patients with a history or examination findings of alcohol dependence, alcohol or drug abuse or suspected abuse. 14.Patients who have participated in a study of an investigational drug 30 days prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with abnormal cortisol response level at Day 28 (i.e. cortisol ≤18 ug/100 mL).Timepoint: 28 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with abnormal plasma cortisol at each time point (≤5 ug/100 mL).Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactShashimohan Keelara
Manipal Acunova
Outcome results
None listed