Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03575780|
Recruitment Status : Not yet recruiting
First Posted : July 3, 2018
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratoses||Drug: KX2-391 Ointment 1%||Phase 1|
This study will be a open-label, single center, pharmacokinetic, and safety study of KX2-391 Ointment administered topically to the face or balding scalp of subjects with actinic keratosis.
The study consists of Screening, Treatment, and Follow-up Periods. Eligible subjects will receive 5 consecutive days of topical treatment, to be applied at the same location. Activity (lesion counts) and safety evaluations will be performed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study will test KX2-391 Ointment 1%.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Open-label, Uncontrolled, Non-randomized, Maximal Use Pharmacokinetic Study to Evaluate the Systemic Exposure and Safety of KX2-391 Ointment 1% When Applied to 25 cm2 of the Face or Balding Scalp in Subjects With Actinic Keratosis|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: KX2-391 Ointment
KX2-391 ointment 1% will be administered once daily over 5 consecutive days
Drug: KX2-391 Ointment 1%
The experimental drug, KX2-391 Ointment 1% will be used in subjects with Clinically typical Actinic Keratosis on the face or balding scalp.
- Amount of KX2-391 Ointment in the blood stream [ Time Frame: 6 Days ]The measurement of KX2-391 Ointment levels in the blood stream over time
- Local Skin Reactions [ Time Frame: 29 Days ]To evaluate the safety of KX2-391 Ointment 1% by the proportion and severity of local skin reactions
- Adverse Events [ Time Frame: 29 Days ]To evaluate the safety of KX2-391 Ointment 1% by the proportion of adverse events
- Abnormal Laboratory Assessments [ Time Frame: 29 Days ]To evaluate the safety of KX2-391 Ointment 1% by the proportion of abnormal laboratory assessments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575780
|Contact: Corey Best||(919) firstname.lastname@example.org|
|Contact: David Cutler, MD, FRCP||(908) email@example.com|
|Study Chair:||David Cutler, MD, FRCP||Athenex, Inc.|