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KX2-391 1%

Phase 1

Actinic Keratoses | Small molecule | Dermatology |IQVIA Holdings, Inc.|Last Updated: Dec 9, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

KX2-391 1% · 1 trial · 1 indication

Phase 1 1
NCT03575780Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic KeratosisActinic Keratoses
COMPLETED18 Analytics
PHASE1COMPLETED
Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis
Actinic Keratoses
NCT0357578018
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Study Endpoints

Primary Endpoints

Amount of KX2-391 Ointment in the blood stream
6 Days

The measurement of KX2-391 Ointment levels in the blood stream over time

Secondary Endpoints

Local Skin Reactions
29 Days
Adverse Events
29 Days
Abnormal Laboratory Assessments
29 Days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KX2-391 OintmentEXPERIMENTALKX2-391 ointment 1% will be administered once daily over 5 consecutive days

Interventions

NameTypeDescription
KX2-391 Ointment 1%DRUGThe experimental drug, KX2-391 Ointment 1% will be used in subjects with Clinically typical Actinic Keratosis on the face or balding scalp.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Males and females ≥18 years old. 2. Able to comprehend and are willing to sign an informed consent form (ICF). 3. At least 5 clinically typical, visible, and discrete AKs on 25 cm2 of the face or balding scalp. 4. Subjects who, in the judgment of the Investigator, are in good...

Countries:United States
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