NCT02337205

Brief Summary

This is a phase 1 study to access the safety and tolerability of KX2-391 ointment in subjects who have Actinic Keratosis. This study will also access the amount of KX2-391 drug that enters the blood stream through dermal application of the ointment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 6, 2018

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

January 5, 2015

Last Update Submit

July 3, 2018

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (2)

  • Overall safety and tolerability assessment as determined by laboratory, adverse event (AE) and serious adverse event (SAE) information.

    Safety assessments will consist of determining and recording all AEs (including for both increasing and decreasing severity) and SAEs; laboratory evaluation for hematology, blood chemistry, and urine analytes; periodic measurement of vital signs and ECGs; and the performance of physical examinations as detailed in Table 3 of the protocol.

    45 days

  • The amount of KX2-391 in the blood stream as determined by pharmacokinetic (PK) analysis: Cmax, Cmin, AUC0-t, AUC0-inf

    Individual PK data will be listed by time. Cmax, Cmin, AUC0-t, AUC0-inf will be calculated for KX2-391 to determine systemic exposure.

    7 days

Secondary Outcomes (1)

  • Actinic Keratosis (AK) lesion count

    45 days

Study Arms (1)

KX2-391 Ointment

EXPERIMENTAL
Drug: KX2-391 Ointment

Interventions

KX2-391 OintmentDRUG

KX2-391 Ointment will be applied at a predetermined concentration to the treatment area for a predetermined time period.

KX2-391 Ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is at least 18 years old
  • Subject has a clinical diagnosis of stable, clinically typical AK
  • Subject has a treatment area on 1 dorsal forearm that in:
  • Cohort 1:
  • Is one contiguous area
  • Measures 25 cm2
  • Contains 4 to 8 AK lesions that are clinically typical.
  • Cohort 2:
  • Is one contiguous area
  • Measures 100 cm2
  • Contains 8 to 16 AK lesions that are clinically typical.
  • All women of childbearing potential (WOCBP) must be:
  • Post-menopausal, defined as at least 50 years of age with amenorrhea for at least 18 months, or
  • Surgically sterile, defined as having undergone a hysterectomy, bilateral oophorectomy or tubal ligation, or otherwise incapable of pregnancy.
  • Pre or perimenopausal and practicing a highly effective method of birth control, including hormonal prescription, oral contraceptives, contraceptive injections, contraceptive patch, and intrauterine device, for the duration of their participation in the study. Abstinence and double-barrier methods do not qualify as highly effective methods of birth control.
  • +13 more criteria

You may not qualify if:

  • Subject has clinically atypical and/or rapidly changing AK lesions on the treatment area
  • Subject has current systemic malignancy
  • Subject has used any of the following systemic therapies within the specific period before Visit 1:
  • Retinoids; 180 days
  • Glucocortico-steroids; 28 days
  • Methotrexate or other anti-metabolites; 28 days
  • Subject has used any of the following topical therapies on the treatment area within the specified period before Visit 1:
  • Retinoids; 90 days
  • Glucocortico-steroids; 14 days
  • Subject has had any of the following of the AK therapies on the treatment area:
  • Medical Therapies within 90 days (or until the site has healed, whichever is longer) before Visit 1:
  • Ingenol mebutate (eg, Picato)
  • fluorouracil (eg, 5-FU; Efudex)
  • Imiquimod (eg, Aldara; Zyclara)
  • Diclofenac with or without hyaluronic acid (eg, Solaraze)
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Related Publications (1)

  • Kempers S, DuBois J, Forman S, Poon A, Cutler E, Wang H, Cutler D, Fang J, Kwan R. Tirbanibulin Ointment 1% as a Novel Treatment for Actinic Keratosis: Phase 1 and 2 Results. J Drugs Dermatol. 2020 Nov 1;19(11):1093-1100. doi: 10.36849/JDD.2020.5576.

    PMID: 33196758DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Douglas Kramer, MD

    Kinex Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 13, 2015

Study Start

December 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 6, 2018

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)