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IDP-123 (Arazlo) in Acne Vulgaris
NCT03168334Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2017
- Primary completion
- Jul 2018
- Countries
- 2
- Sponsor
- Valeant Pharmaceuticals
- Modality
- Orthosteric Ligands
- Drugs
- tazarotene
- Conditions
- acne vulgaris
01
Overview
Phase 3, randomised, double-blind trial in acne vulgaris comparing IDP-123 Lotion with IDP-123 Vehicle Lotion (2 arms). Primary endpoints: Absolute Change in Mean Lesion Counts at Week 12 and Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to 'Clear' or 'Almost… Started Jul 2017; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
IDP-123 Lotion
Tazarotene 0.045% Lotion
IDP-123 Vehicle Lotion
Vehicle Lotion
03
Who it enrols
Patients 9+ with moderate to severe acne vulgaris (EGSS 3-4), 20-50 inflammatory lesions, 25-100 non-inflammatory lesions, and <=2 nodules.
04
Endpoints
Primary
Absolute Change in Mean Lesion Counts at Week 12
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to 'Clear' or 'Almost…
Secondary
Percentage Change in Mean Lesion Counts at Week 12
Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)
Percentage Change in Mean Lesion Counts at Week 8
Percentage Change in Mean Lesion Counts at Week 4
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