Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp
NCT ID: NCT02838628
Last Updated: 2021-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
168 participants
INTERVENTIONAL
2016-04-11
2017-12-22
Brief Summary
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Detailed Description
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The study consists of Screening, Treatment, and Follow-up Periods. Eligible participants were received 3 or 5 consecutive days of topical treatment, applied at the study site. Blood samples for PK analysis were collected. Activity (lesion counts) and safety evaluations were performed.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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KX2-391 50 mg (Days 1 to 5)
Participants were applied 50 milligrams (mg) of KX2-391 Ointment 1% topically on face or scalp in 25 centimeter square (cm\^2) treatment area, once daily for 5 consecutive days.
50 mg of KX2-391 Ointment 1%
Dose: 50 mg; Route of administration: Topical
KX2-391 50 mg (Days 1 to 3)
Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm\^2 treatment area, once daily for 3 consecutive days.
50 mg of KX2-391 Ointment 1%
Dose: 50 mg; Route of administration: Topical
Interventions
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50 mg of KX2-391 Ointment 1%
Dose: 50 mg; Route of administration: Topical
50 mg of KX2-391 Ointment 1%
Dose: 50 mg; Route of administration: Topical
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of stable, clinically typical actinic keratosis
3. A define treatment area on the face or scalp
4. Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with KX2-391 Ointment
5. Males who have not had a vasectomy must agree to use barrier contraception
6. Participants who in the judgment of the Investigator, are in good general health
7. Willing to avoid excessive sun exposure
8. Able to comprehend and are willing to sign an informed consent form (ICF)
Exclusion Criteria
2. Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence
3. Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1
4. Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
5. Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
6. A history of sensitivity and/or allergy to any of the ingredients in the study medication
7. A skin disease or condition that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an unacceptable risk by study participation
8. Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation
9. Females who are pregnant or nursing
10. Participated in an investigational drug trial during which an investigational study medication was administered within 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
18 Years
ALL
No
Sponsors
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Athenex, Inc.
INDUSTRY
Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Jane Fang, MD
Role: STUDY_CHAIR
Kinex Pharmaceuticals Inc.
Locations
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Center for Dermatology Clinical Research
Fremont, California, United States
eStudy Site
La Mesa, California, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, United States
Horizons Clinical Research Center
Denver, Colorado, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
International Dermatology Research
Miami, Florida, United States
Compass Research
Orlando, Florida, United States
Forward Clinical Trials, Inc.
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Dermatology and Laser Center of Charleston
Charleston, South Carolina, United States
Institute of Clinical Research - Tennessee, LLC
Murfreesboro, Tennessee, United States
J&S Studies, Inc.
College Station, Texas, United States
The Center for Skin Research
Houston, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Dermatology Clinical Research Center
San Antonio, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1173-5677
Identifier Type: OTHER
Identifier Source: secondary_id
KX01-AK-002
Identifier Type: -
Identifier Source: org_study_id
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