Health Condition 1: null- Mild to moderate plaque type psoriasis (scalp and non-scalp) Health Condition 2: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Clobetasol propionate topical foam 0.05%: Self-administered by patients twice daily (morning and evening) for two weeks
Control Intervention1: Clobetasol propionate lotion 0.05%: Self-a
Sponsors
Torrent Pharamceutical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients of age 18 years or older. 2. Patients with mild to moderate plaque-type psoriasis, as defined by ISGA score of 2-3 at enrolment involving 3. Patients must have a target lesion ( >2 cm2) with a score of 2-3 (on a scale of 0 to 5) for each of erythema, scaling and plaque thickness. 4. Patients with ability and willingness to follow the study procedures attend all scheduled visits and successfully complete the study. 5. Patients willing to give informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with known allergy or sensitivity to clobetasol or other topical corticosteroids or any other component of investigational formulation. 2. Patients whose psoriasis involves the face, nails, palms, soles or intertriginous sites. 3. Severe, uncontrolled manifestation of any disease including psoriasis. 4. Use of systemic antipsoriatic therapy (e.g., corticosteroids, retinoids, methotrexate, psoralen and ultraviolet light, cyclosporine) within the past 4 weeks 5. Patients who have taken or currently on biologics treatment such as e.g., alefacept, etanercept, adalimumab. 6. Use of topical treatment which have a known beneficial effect on psoriasis, including but not limited to corticosteroid, retinoids, vitamin D derivatives, tar or anthralin within the past 2 weeks. 7. Introduction or change in dosage of systemic medications for other medical conditions which are known to affect psoriasis (e.g., lithium, β-blockers etc.) within the past 4 weeks. 8. The expectation of exposure to strong sunlight or UV therapy during the course of the study; or any condition that, in the judgment of the investigator, would put the patient at unacceptable risk for participation in the study. 9. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C. 10. History of malignancy in last 5 years. 11. Current drug or alcohol abuse. 12. Patient with clinically significant abnormal laboratory investigation. 13. Use of any investigational drug or device therapy within the past 4 weeks. 14. Pregnant women, women who are breast feeding or women of reproductive potential who are neither surgically sterilized nor willing to use effective contraceptive methods during the course of the study. 15. Men wishing to father a child during the course of the study or not ready to use adequate means of contraception throughout the study. 16. Patient who in the opinion of the investigator would not be suitable candidate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with Investigatorâ??s static global assessment scores of 0 or 1 at week 2.Timepoint: Screening, Day 0, Week 1 and Week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of mean vehicle acceptance score between treatment groups at week 2Timepoint: Week 2;Mean change in scores of target lesion signs of psoriasis (erythema, scaling, plaque thickness) and pruritus from baseline to week 2Timepoint: Screening, Day 0, Week 1 and Week 2;Percentage of patients with Investigatorâ??s static global assessment scores of 0 or 1 in scalp and non-scalp psoriasis groups at week 2Timepoint: Screening, Day 0, Week 1 and Week 2;Percentage of patients with Subjectâ??s global assessment score of 0 or 1 at week 2Timepoint: Day 0, Week 1 and Week 2 | — |
Countries
India
Contacts
Public ContactDr Sushil Kumar Anand
Torrent Pharmaceuticals Ltd, Torrent Research Centre
Outcome results
None listed