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Alclometasone dipropionate

Phase 2

Eczema | Small molecule | Immunology |GSK plc|Last Updated: Sep 5, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment310
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02075632Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate CreamPHASE2 COMPLETED 310Sep 1, 2006Nov 1, 2006Sep 5, 2014 -
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Study Endpoints
Primary Endpoints
Number of Participants With Incorrect Duration of Use of the Medication
Day1-Day 14

Incorrect duration of use was defined as the use of study medication for more than 7 consecutive days and/or more than three times in a day. Participants were asked the reasons of doing so and they were allowed to select multiple reasons also, if applicable.

Secondary Endpoints
Number of Times Per Day Participants Used the Product
Day1-Day14
Number of Days of Use
Day 1-Day 14
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Alclometasone dipropionate creamEXPERIMENTALAlclometasone dipropionate cream 0.05% will be applied by the participants topically on the affected areas per label instructions for 14 days.
Interventions
NameTypeDescription
Alclometasone dipropionate creamDRUGAlclometasone dipropionate cream 0.05% (15 g)
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Eligibility Criteria
Age Range12 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Age: At least 12 years of age. * Condition: Currently experiencing itch associated with one of the following skin conditions: * psoriasis or eczema, * minor skin conditions such as those caused by poison ivy, oak, or sumac, insect bites, or use of cosmetics, soaps, deterg...

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