comparison of effectiveness and safety of topical sequential therapy with tazarotene and calcitriol with monotherapy of calcitriol or tazarotene in patients with stable plaque psoriasis.
- Conditions
- Health Condition 1: L408- Other psoriasisHealth Condition 2: null- stable plaque psoriasis
- Registration Number
- CTRI/2020/03/023715
- Lead Sponsor
- nil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Males or non pregnant females 18 years of age or older.
Subjects with a clinical diagnosis of stable plaque psoriasis of atleast 3 months.
Subjects with 5 to 10 percent Body surface area involvement.
Lesions did not include the face, scalp, groin, hands and feet.
Subjects able to complete the study and to comply with study instructions.
Subjects willing to give written informed consent.
Females who were pregnant, lactating or planning a pregnancy.
Current diagnosis of unstable forms of psoriasis in the treatment area including guttate,erythrodermic,exfoliative or pustular psoriasis.
Other inflammatory skin disease in the treatment area that confounded the evaluation of the plaque psoriasis ,for example atopic dermatitis,contact dermatitis,tinea corporis.
Presence of pigmentation, extensive scarring or pigmented lesions in the treatment areas,which could interfere with the rating of efficacy parameters.
History of psoriasis unresponsive to topical treatments.
History of hypersensitivity to any component of the test product or reference listed drug.
Current or past history of hypercalcemia,vitamin D toxicity,severe hepatic disorders.
Current immunosuppression.
Use within one month prior to baseline of systemic steroids,systemic antibiotics,systemic antipsoriatic treatment,PUVA therapy,UVB therapy or systemic anti-infammatory agents,calcium supplements.
Use within 2 weeks prior to baseline of topical anti-psoriatic drugs(for example-salicylic acid,anthralin,coaltar,calcipotriene,tazarotene), topical corticosteroids,immunosuppressive drugs(for example- tacrolimus,pimecrolimus),or topical retinoids.
Use of topical products other than the assigned treatment (including moisturizers,new brands of make-up,creams,ointments,lotions and powders)applied on or near the treatment area.
Initiation of or changes to non antipsoriatic concomitant medication that could affect psoriasis (for example-beta blockers,lithium) during study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.mean difference in erythema,scaling and induration. <br/ ><br>2.mean difference in patients own assessment of disease severity.Timepoint: 4,8,12 and 16 weeks.
- Secondary Outcome Measures
Name Time Method 1.period of remission. <br/ ><br>2.number of adverse events reported.Timepoint: 4,8,12 and 16 weeks