Scalp Psoriasis
Conditions
Brief summary
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.
Detailed description
Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis
Interventions
DRUGBetamethasone Scalp Suspension 0.064%;0.0005%
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
DRUGTaclonex®
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
DRUGPlacebo topical suspension
applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy male or non-pregnant female aged ≥18 years * All male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug * Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits * A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp
Exclusion criteria
* Female subjects who were pregnant, nursing, or planning to become pregnant during study participation * Known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs * Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment success on the Physician's Global Assessment (PGA) of disease severity | Study Week 4 (Day 28 ± 4 days) | The proportion of subjects in each treatment group with treatment success (defined as none or minimal, a score of 0 or 1, within the treatment area) on the PGA of disease severity |
| clinical success on the Physician's Global Assessment (PASI) of disease severity | Study Week 4 (Day 28 ± 4 days) | The proportion of subjects in each treatment group with clinical success (defined as clear or almost clear, a score of 0 or 1, at the target lesion site) on the PASI. Each psoriatic sign of scaling, erythema and plaque elevation should have a score of 0 or 1 for the subject to be considered a clinical success. The target lesion is to be identified at Baseline as the most severe lesion. |
Countries
United States
Outcome results
None listed