CTRI/2017/10/010121
Completed
Phase 3
A Multicentric, assessor-blind, randomized, active controlled, parallel design study comparing efficacy and safety of clobetasol propionate topical foam 0.05% vs. clobetasol propionate lotion 0.05% in patients with mild to moderate plaque type psoriasis (scalp and non-scalp)
Torrent Pharamceutical Ltd0 sites232 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Mild to moderate plaque type psoriasis (scalp and non-scalp)Health Condition 2: L400- Psoriasis vulgaris
- Sponsor
- Torrent Pharamceutical Ltd
- Enrollment
- 232
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<\=10 % of total body surface area.
- •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
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
A multicenter clinical trial for the comparison of efficacy and safety in the treatment of elevated intraocular pressure in adult patients with glaucoma.Health Condition 1: H401- Open-angle glaucomaCTRI/2023/06/054478AZAD Pharma AG208
Completed
Not Applicable
Bioequivalence study between Brinzolamide plus in adult patients with open-angle glaucoma or ocular hypertension.Health Condition 1: H49-H52- Disorders of ocular muscles, binocular movement, accommodation and refractionCTRI/2020/09/027727Pharmathen SA204
Completed
Not Applicable
A bioequivalence study Brimonidine tartrate 2 mg/ml & Timolol 5 mg/ml in the treatment of elevated intraocular pressure in adult patients with chronic open-angle glaucoma or ocular hypertension.Health Condition 1: H409- Unspecified glaucomaCTRI/2021/12/038477Pharmathen SA233
Completed
Phase 4
Phlogam and Disperzyme use for reducing pain and swelling after small surgeryCTRI/2017/12/010804Aksigen Hospital Care309
Active, not recruiting
Phase 1
A Phase III study of efficacy and safety of ligelizumab in the treatment of Chronic Spontaneous Urticaria in adolescents and adults inadequately controlled with H1-antihistaminesChronic Spontaneous UrticariaMedDRA version: 20.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2018-000839-28-BGovartis Pharma AG1,072