A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis

Updated on 25 March 2021


A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis


This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.

Clinical Study IdentifierTX150172
Last Modified on25 March 2021


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Inclusion Criteria

Male or non-pregnant, non-lactating female, at least 18 years of age
Female subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized or postmenopausal for at least 2 years)
A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs
Scalp psoriasis consistent with at least moderate disease severity (grade ≥ 3) using the Physician's Global Assessment (PGA) of disease severity
Plaque elevation of at least moderate severity (grade ≥ 3) at the scalp target lesion site using the Psoriasis Area Severity Index (PASI). The most severe lesion at Baseline will be identified as the scalp target lesion
Agree to stop use of all other topical or systemic antipsoriatic treatments, corticosteroids, immunosuppressive drugs, calcium supplements and Vitamin D supplements or Vitamin D analogs at a dose > 400 IU/day during the study
Currently in general good health and free from any clinically significant disease, other than scalp psoriasis and psoriasis vulgaris, that may interfere with the study evaluations
Willing and able to understand and comply with the requirements of the study, apply IP as instructed, attend required study visits, comply with study prohibitions, and be able to complete the study

Exclusion Criteria

Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis
Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (eg, atopic dermatitis, contact dermatitis, tinea capitis)
History of hypersensitivity to any component of TEST or RLD
Current or past history of hypercalcemia, hypercalciuria, vitamin D toxicity, severe renal insufficiency, or hepatic disorders
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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