To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:October 20, 2017
End Date:October 25, 2018

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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Taclonex® Topical Suspension (LEO Pharma Inc.) in the Treatment of Scalp Psoriasis

This is a phase III, randomized, double-blind, placebo-controlled, parallel- group,
multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and
betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd
to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the
treatment of scalp psoriasis.


Inclusion Criteria:

1. Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.

2. 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.

3. A PGA of disease severity of the scalp psoriasis consistent with at least moderate
disease severity (Grade ≥ 3).

4. A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target
lesion site. The most severe scalp lesion at baseline should be identified as the
target lesion.

Exclusion Criteria:

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
exfoliative, or pustular psoriasis.

2. Other inflammatory skin disease in the scalp that may confound the evaluation of the
scalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis).

3. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the
scalp that could interfere with the rating of efficacy parameters.

4. Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic
(thinning) skin on the scalp.

5. History of psoriasis unresponsive to topical treatments.

6. Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB
during the study.
We found this trial at
28
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Ann Arbor, MI
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Encinitas, CA
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Forest Hills, NY
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Fountain Inn, South Carolina 29644
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Fridley, MN
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Mount Pleasant, South Carolina 29464
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South Bend, IN
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2136
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Tampa, FL
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