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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.

To compare the safety and efficacy of sequential therapy with topical tazarotene and calcitriol versus monotherapy of tazarotene and calcitriol in patients with stable plaque psoriasis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/03/023715
Enrollment
120
Registered
2020-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L408- Other psoriasis Health Condition 2: null- stable plaque psoriasis

Interventions

Intervention1: tazarotene 0.1% cream: Group A applied tazarotene 0.1% cream for 4 weeks followed by calcitriol 0.0003% cream for next 4 weeks. Group B applied calcitriol 0.0003% cream for 4 weeks foll

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1.mean difference in erythema,scaling and induration. 2.mean difference in patients own assessment of disease severity.Timepoint: 4,8,12 and 16 weeks.

Secondary

MeasureTime frame
1.period of remission. 2.number of adverse events reported.Timepoint: 4,8,12 and 16 weeks

Countries

India

Contacts

Public Contactjaspreet kaur boparai
jaspreetkaurboparai@gmail.com9971844229

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026