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to study the effect and safety of two products in treatment of psoriasis.

Double-blind, multicenter, prospective, comparative study to evaluate the efficacy and safety of 0.05% halobetasol propionate ointment and 0.05% clobetasol propionate ointment in subjects with chronic, localized plaque psoriasis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2012/09/003001
Enrollment
200
Registered
2012-09-17
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: null- Clinically diagnosed localized, plaque psoriasis vulgaris or Palmoplanter psoriasis

Interventions

Intervention1: Halobetasol propionate (0.05%) ointment: applied twice daily once in morning and other application in evening on the target lesion according to FTU (Finger Tip Unit) method for 14 days

Sponsors

Glenmark Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects between 18 to 60 yrs ( treatment naïve patients or patients receiving treatments such as Corticosteroids, Methotrexate or PUVA should be given a wash out period of 10 days) 2. Clinically diagnosed localized, plaque psoriasis vulgaris or Palmoplanter psoriasis affecting maximum up to 10-20% of the total body surface area. The size of lesion selected is approximately 4 to 10 cm2 3. Subjects must provide written informed consent and comply to the protocol.

Exclusion criteria

Exclusion criteria: 1. Subjects with psoriatic erythroderma, generalized pustular psoriasis 2. Pregnancy & Lactation 3. Concomitant tuberculosis 4. Syphilis 5. Uncontrolled Diabetes mellitus 6. Leukemia

Design outcomes

Primary

MeasureTime frame
1. Investigatorâ??s clinical assessment on LPSI score to evaluate reduction of erythema, scaling, thickness. 2. Assessment of Pruritus 3. Global Evaluation 4. Subjects observation Timepoint: 0day- 7days- 14 days

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Amanjit Ahluwalia

Glenmark pharmaceuticals ltd

amanjita@glenmarkpharma.com9819943075

Outcome results

None listed

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