BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis
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ClinicalTrials.gov Identifier: NCT03122353 |
Recruitment Status :
Completed
First Posted : April 20, 2017
Last Update Posted : March 7, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Scalp Psoriasis | Drug: Calcipotriene and betamethasone suspension Drug: Taclonex Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 699 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis |
Actual Study Start Date : | April 11, 2017 |
Actual Primary Completion Date : | November 15, 2017 |
Actual Study Completion Date : | November 15, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Calcipotriene Hydrate and Betamethasone
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
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Drug: Calcipotriene and betamethasone suspension
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Other Name: Calcipotriene, betamethasone |
Active Comparator: Taclonex
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
|
Drug: Taclonex
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
Other Name: Calcipotriene, betamethasone |
Placebo Comparator: Placebo
Topical suspension without active ingredient
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Drug: Placebo
vehicle used as placebo
Other Name: Vehicle |
- Psoriasis Area Severity Index (PASI) [ Time Frame: at Day 1, Day 28 ]To evaluate the change in clinical outcome of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis. From baseline to end of study.
- Physician Global Assessment (PGA) [ Time Frame: at Day 1, Day 28 ]To evaluate the change in global severity of skin of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex, and Vehicle for scalp psoriasis. From baseline to end of study.
- Body Surface Area (BSA) [ Time Frame: at Day 1 ]To evaluate the total body area of skin affected by psoriasis.
- Adverse Events and Serious Adverse Events [ Time Frame: at Day 28 ]Risk for adverse events and serious adverse events for exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122353

Study Director: | Jim Joffrion | Catawba Research |
Responsible Party: | Tolmar Inc. |
ClinicalTrials.gov Identifier: | NCT03122353 |
Other Study ID Numbers: |
TOL2708C |
First Posted: | April 20, 2017 Key Record Dates |
Last Update Posted: | March 7, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Calcitriol Betamethasone Betamethasone Valerate Betamethasone-17,21-dipropionate Betamethasone benzoate Calcipotriene Betamethasone sodium phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Calcium-Regulating Hormones and Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Vitamins Micronutrients Nutrients Growth Substances Bone Density Conservation Agents |