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

Use our guide to learn which trials are right for you!

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
sites
629
mi
from 43215
Fridley, MN
Click here to add this to my saved trials
164
mi
from 43215
Ann Arbor, MI
Click here to add this to my saved trials
1069
mi
from 43215
Austin, TX
Click here to add this to my saved trials
987
mi
from 43215
College Station, TX
Click here to add this to my saved trials
1162
mi
from 43215
Denver, CO
Click here to add this to my saved trials
1947
mi
from 43215
Encinitas, CA
Click here to add this to my saved trials
485
mi
from 43215
Forest Hills, NY
Click here to add this to my saved trials
Fountain Inn, South Carolina 29644
367
mi
from 43215
Fountain Inn, SC
Click here to add this to my saved trials
2088
mi
from 43215
Fremont, CA
Click here to add this to my saved trials
1751
mi
from 43215
Henderson, NV
Click here to add this to my saved trials
322
mi
from 43215
High Point, NC
Click here to add this to my saved trials
283
mi
from 43215
Knoxville, TN
Click here to add this to my saved trials
1767
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
188
mi
from 43215
Louisville, KY
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
979
mi
from 43215
Miramar, FL
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
524
mi
from 43215
Mount Pleasant, SC
Click here to add this to my saved trials
331
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
189
mi
from 43215
New Albany, IN
Click here to add this to my saved trials
422
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
341
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
355
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
626
mi
from 43215
Saint Joseph, MO
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
1985
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
205
mi
from 43215
South Bend, IN
Click here to add this to my saved trials
831
mi
from 43215
Tampa, FL
Click here to add this to my saved trials