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Vehicle control, 2x/day

Phase 2

Rosacea | Small molecule | Dermatology |AbbVie Inc.|Last Updated: May 30, 2011

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00249782A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.PHASE2 COMPLETED 400 — — Nov 1, 2005May 1, 2006May 30, 201126 United States
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Study Endpoints
Primary Endpoints
Efficacy: Percent change and change from baseline in inflammatory lesion counts;
"Success" rate, defined as proportion of subjects with a score of 0 or 1 and at least a 2 point improvement from baseline on the IGA scale;
Erythema & telangiectasia scores;
Lesion counts over time
Secondary Endpoints
Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs
Other: Plasma dapsone concentrations
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Vehicle control, 2x/dayDRUG -
ACZONE (dapsone) Gel, 5%, 2x/dayDRUG -
ACZONE (dapsone) Gel, 5%, 1x/dayDRUG -
MetroGel® (metronidazole gel), 1.0% 1x/dayDRUG -
ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: To be eligible for the study, subjects must fulfill all of the following criteria: 1. Men or women ≥18 years of age. 2. A diagnosis of papulopustular rosacea, with ≥10 inflammatory lesions (papules and/or pustules) above the mandibular line at baseline. 3. An Investigator Globa...

Countries:United States
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