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AGN-190168

Phase 1

Acne Vulgaris | Small molecule | Dermatology |AbbVie Inc.|Last Updated: Apr 30, 2015

Target and mechanism

ModalitySmall molecule

Also known as AGN-190168 Formulation 1, AGN-190168 Formulation 2

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

AGN-190168 · 1 trial · 1 indication

Phase 1 1
NCT02218034Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne VulgarisAcne Vulgaris
COMPLETED78 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
Acne VulgarisUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Plasma Level (Cmax) of AGN-190168
Day 29
Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
Day 29
Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
Day 29
Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale
Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AGN-190168 Formulation 1EXPERIMENTALAGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
AGN-190168 Formulation 2EXPERIMENTALAGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
TAZORAC® Gel 0.1%ACTIVE_COMPARATORTAZORAC® Gel 0.1% (tazarotene gel 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
TAZORAC® Cream 0.1%ACTIVE_COMPARATORTAZORAC® Cream 0.1% (tazarotene cream 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.

Interventions

NameTypeDescription
AGN-190168 Formulation 1DRUGAGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
AGN-190168 Formulation 2DRUGAGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
tazarotene gel 0.1%DRUGTazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
tazarotene cream 0.1%DRUGTazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of acne vulgaris on the face * No tobacco use for the past 30 days, and willing to refrain from nicotine use during the study * Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weat...

Countries:United States
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