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AGN-190168 Formulation 1

Phase 1

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

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 Formulation 1 · 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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Frequently asked questions about AGN-190168 Formulation 1

What is AGN-190168 Formulation 1 used for?

AGN-190168 Formulation 1 is an investigational small molecule being developed for the treatment of acne vulgaris. It is in Phase 1 clinical development. The drug is being studied in patients with acne vulgaris, and it is not yet approved by regulatory authorities.

Who makes AGN-190168 Formulation 1?

AGN-190168 Formulation 1 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug.

What phase is AGN-190168 Formulation 1 in?

AGN-190168 Formulation 1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development.

What clinical trials is AGN-190168 Formulation 1 in?

AGN-190168 Formulation 1 has one completed clinical trial, identified as NCT02218034. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of the drug in 78 subjects with acne vulgaris in the United States. The trial was active-controlled and included participants aged 12 years and older.

Is AGN-190168 Formulation 1 the same as AGN-190168?

AGN-190168 Formulation 1 is a specific formulation of the investigational drug AGN-190168. The clinical trial NCT02218034 refers to AGN-190168, and the formulation is being studied for the treatment of acne vulgaris. No other alternative names have been disclosed.