Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type
psoriasis: results of two multicenter, randomized, double-blind,
vehicle-controlled, phase III clinical trials.
Author(s): Feldman SR, Matheson R, Bruce S, Grande K, Markowitz O, Kempers S, Brundage T,
Wyres M; U0267-301 & 302 Study Investigators.
Collaborators: Abramovits W, Draelos Z, Kerdel FA, Kimball A, Kircik L, Swinyer
LJ, Wiltz H, Davis SA, Dhawan S, Frankel EH, Kaplan DL, Rich P, Shulman B,
Solomon JA, Tschen E.
Affiliation(s): Wake Forest University Health Sciences, Winston-Salem, NC 27104, USA.
feldman@wfubmc.edu
Publication date & source: 2012, Am J Clin Dermatol. , 13(4):261-71
BACKGROUND: Topical calcipotriene is frequently prescribed for the treatment of
plaque-type psoriasis. Calcipotriene is currently available in the US as an
ointment, a solution, a cream, and in a fixed-dose combination ointment with
betamethasone dipropionate. Calcipotriene 0.005% has recently been formulated as
a foam using a novel aqueous-based formulation to provide a new topical treatment
option for patients with psoriasis.
OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of
topical calcipotriene 0.005% foam for the treatment of mild to moderate
plaque-type psoriasis.
DESIGN: Two identical, randomized, double-blind, vehicle-controlled, 8-week phase
III clinical trials.
INTERVENTION: Subjects with plaque-type psoriasis affecting 2-20% of the body
surface area, with an identifiable target lesion affecting the trunk or
extremities, were randomized in a 2:1 ratio to calcipotriene foam (n = 437) or
vehicle foam (n = 222). Study medication was applied twice daily for 8 weeks.
OUTCOME MEASURES: Treatment success was defined as a score of 0 or 1 (clear or
almost clear) on the Investigator's Static Global Assessment (ISGA) psoriasis
rating scale and a minimum improvement of ISGA score of at least 2 grades from
baseline. Predefined target lesions were assessed for erythema, scaling, and
plaque thickness. Primary endpoint was the proportion of subjects in each
treatment group who achieved treatment success after 8 weeks, analyzed on an
intent-to-treat (ITT) basis. In the primary endpoint analysis, subjects missing
8-week outcomes data were classified as treatment failures regardless of their
outcomes at earlier evaluations. As part of the sensitivity analysis, a
last-observation-carried-forward (LOCF) approach to impute missing 8-week
efficacy outcomes also examined treatment. Secondary endpoints included treatment
success as a function of baseline ISGA score (mild or moderate), ISGA score of 0
or 1 (clear or almost clear), and effects of treatment on target lesion. Adverse
events (AEs) were recorded throughout the study.
RESULTS: In the ITT population of Study 1, treatment success after 8 weeks was
achieved by 14% of subjects in the calcipotriene foam group versus 7% of subjects
in the vehicle foam group (p = 0.058). In the LOCF analysis, treatment success
was achieved by more subjects with calcipotriene foam than with vehicle foam (15%
vs 7%; p = 0.034). In Study 2, treatment success was achieved by more subjects in
the calcipotriene foam group for the primary endpoint (27% vs 16%; p = 0.016) and
the LOCF analysis (28% vs 16%; p = 0.010). Subjects in the calcipotriene foam
group exhibited better response rates than did the vehicle foam group for most of
the secondary outcomes. Calcipotriene foam was safe with an overall incidence of
AEs similar to those experienced in the vehicle foam group. Application-site
reactions were noted in approximately 1-2% of subjects in each group. No AE was
reported in more than 2% of subjects in the calcipotriene foam group. Treatment
was discontinued because of AEs in approximately 2% of subjects in both groups.
CONCLUSIONS: In two identically designed, phase III clinical trials,
calcipotriene 0.005% foam was safe and effective for the treatment of mild to
moderate plaque-type psoriasis for up to 8 weeks. Clinical Trial Registration:
Registered at clinicaltrials.gov: NCT00688519 and NCT00689481.
Erratum in
Am J Clin Dermatol. 2912 Dec 1;13(6):422.
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