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Calcipotriene Foam

Phase 3

Psoriasis | Small molecule | Dermatology |GSK plc|Last Updated: Jan 18, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment363

FDA Designations

No designations recorded

Clinical trial landscape

Calcipotriene Foam · 1 trial · 1 indication

Phase 3 1
NCT01139580The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body PsoriasisPsoriasis
COMPLETED363 Analytics
PHASE3COMPLETED
The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method
Week 8

The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.

Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)
Week 8

The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.

Secondary Endpoints

Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8
Baseline and Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8
Baseline and Week 8
Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8
Baseline and Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Calcipotriene FoamEXPERIMENTALCalcipotriene Foam 0.005%,
Vehicle FoamPLACEBO_COMPARATORVehicle Foam

Interventions

NameTypeDescription
Calcipotriene FoamDRUGCalcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
Vehicle FoamDRUGVehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed. * Male or female subjects at least 12 years old and in good general...

Countries:United States
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Frequently asked questions about Calcipotriene Foam

What is Calcipotriene Foam used for?

Calcipotriene Foam is used for the treatment of psoriasis, a skin condition. It is being studied for use in patients with scalp and body psoriasis. The foam is a small molecule therapy being developed by GSK plc for dermatological use.

What does Calcipotriene Foam target?

Calcipotriene Foam is a small molecule therapy. The specific molecular target of Calcipotriene Foam is not disclosed in the available information. It is being investigated for the treatment of psoriasis, a condition affecting the skin.

Who makes Calcipotriene Foam?

Calcipotriene Foam is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and effectiveness of this treatment for psoriasis.

What phase is Calcipotriene Foam in?

Calcipotriene Foam is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being studied for the treatment of psoriasis.

What clinical trials is Calcipotriene Foam in?

Calcipotriene Foam has one completed Phase 3 clinical trial, identified as NCT01139580. This study evaluated the safety and effectiveness of Calcipotriene Foam in subjects with scalp and body psoriasis. The trial enrolled 363 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is Calcipotriene Foam the same as calcipotriene?

Calcipotriene Foam is a formulation of calcipotriene, a vitamin D analog used to treat psoriasis. The foam is a specific delivery form of this active ingredient, designed for application to the scalp and body. It is being developed by GSK plc for the treatment of psoriasis.