Actinic KeratosisPhase 2NCT02838628
Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp
A Phase 2 study testing 50 mg of KX2-391 Ointment 1% in people with Actinic Keratosis, run by Almirall, S.A. at 16 sites in United States.
Trial summary
In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- 50 mg of KX2-391 Ointment 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 16 sitesUnited States
- Study dates
- 11 Apr 2016to 22 Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥18 years old
- Clinical diagnosis of stable, clinically typical actinic keratosis
- A define treatment area on the face or scalp
- 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
- Males who have not had a vasectomy must agree to use barrier contraception
- Participants who in the judgment of the Investigator, are in good general health
- Willing to avoid excessive sun exposure
- Able to comprehend and are willing to sign an informed consent form (ICF)
Who cannot join
- Clinically atypical and/or rapidly changing AK lesions on the treatment area
- 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
- 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
- Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
- Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
- A history of sensitivity and/or allergy to any of the ingredients in the study medication
Show all 10Show fewer
- 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
- 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
- Females who are pregnant or nursing
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Dermatology and Laser Center of Charleston
Charleston, South Carolina, 29414
J&S Studies, Inc.
College Station, Texas, 77845
Clinical Research of South Florida
Coral Gables, Florida, 33134
Horizons Clinical Research Center
Denver, Colorado, 80220
Center for Dermatology Clinical Research
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
The Center for Skin Research
Houston, Texas, 77056
eStudy Site
La Mesa, California, 91942
International Dermatology Research
Miami, Florida, 33144
Institute of Clinical Research - Tennessee, LLC
Murfreesboro, Tennessee, 37130
Compass Research
Orlando, Florida, 32806
Palmtree Clinical Research, Inc.
Palm Springs, California, 92262
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Dermatology Clinical Research Center
San Antonio, Texas, 78229
Forward Clinical Trials, Inc.
Tampa, Florida, 33624
Palm Beach Research Center
West Palm Beach, Florida, 33409
About this study
Official title: A Phase 2a, Open-Label, Multicenter, Activity and Safety Study of KX2-391 Ointment 1% in Subjects With Actinic Keratosis on the Face or Scalp
In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.
Read the detailed description
This study was an open-label, multicenter, activity, safety, tolerability, and PK study of KX2-391 Ointment administered topically to the face or scalp of participants with AK.
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
- Actinic Keratosis
- Being tested
- 50 mg of KX2-391 Ointment 1%
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg of KX2-391 Ointment 1%Drug
Dose: 50 mg; Route of administration: Topical
50 mg of KX2-391 Ointment 1%Drug
Dose: 50 mg; Route of administration: Topical
| Study group | Role | What they receive |
|---|---|---|
| KX2-391 50 mg (Days 1 to 5) | Experimental | 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. Receives: Drug: 50 mg of KX2-391 Ointment 1% |
| KX2-391 50 mg (Days 1 to 3) | Experimental | 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. Receives: Drug: 50 mg of KX2-391 Ointment 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complete Response of Actinic Keratosis
Complete response rate was defined as the percentage of participants achieving 100% clearance in the treatment area on the face or scalp at Day 57.
Measured: Day 57
Secondary outcomes (13)
Percentage of Participants With Partial Response of Actinic Keratosis
Partial response rate was defined as the percentage of participants achieving more than or equal to 75% clearance in the treatment area on the face or scalp at Day 57.
Measured: Day 57
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57
Overall changes from baseline in actinic keratosis lesion counts has been reported.
Measured: Baseline, Days 8, 15, 29 and 57
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational Product (IP). An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs.
Measured: Baseline up to Day 57 (Treatment and follow-up period)
Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an IP. An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs.
Measured: From Day 57 up to 12-months post-Day 57 (Recurrence follow-up period)
Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs)
Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. Local skin reactions assessment included signs of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration on the treatment area. These signs were assessed using a 5-point grading scale ranging from 0 (not present) to 4 (worst), where (grade 0 = absent, grade 1 = slight, grade 2 = moderate, grade 3 = severe, grade 4 = very severe).
Measured: Day 57
Number of Participants With Clinically Significant Abnormalities in Laboratory
Laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance was determined by the investigator.
Measured: Baseline to Day 57
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Measured: Baseline up to Day 57
Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)
ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator.
Measured: Baseline up to Day 57
Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE)
A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
Measured: Baseline up to Day 57
Maximum Observed Plasma Concentration (Cmax) of KX2-391 of KX2-391
Cmax was defined as the maximum observed plasma concentration obtained directly from the concentration versus time curve.
Measured: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Area Under the Plasma Concentration Time Curve From Time 0 to the Last Sampling Time (AUCt) of KX2-391
Area under the plasma concentration versus time curve from time zero to the last sampling time (t) at which the concentration is at or above the LLOQ. AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Minimum Observed Plasma Concentration (Cmin) of KX2-391
Cmin was defined as minimum observed plasma concentration obtained directly from the concentration versus time curve.
Measured: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Accumulation Ratio (R)
Ratio calculated from AUC and Cmax found on the last day of treatment and Day 1.
Measured: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start11 Apr 2016
- Primary completion11 Jan 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Athenex, Inc.
- Responsible party
- Sponsor
- Investigators
- Jane Fang, MD, Study chair, Kinex Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838628
- Sponsor's protocol ID
- KX01-AK-002
- Other IDs
- U1111-1173-5677
- Status last verified
- Mar 2021
- First submitted
- 18 Jul 2016
- Last updated
- 14 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33196758
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-Label, Multicenter, Activity and Safety Study of KX2-391 Ointment 1% in Subjects With Actinic Keratosis on the Face or Scalp
- ClinicalTrials.gov ID
- NCT02838628
- Acronym / sponsor ID
- KX01-AK-002
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Athenex, Inc.
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 11 Jan 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Posted 14 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.
Detailed description
This study was an open-label, multicenter, activity, safety, tolerability, and PK study of KX2-391 Ointment administered topically to the face or scalp of participants with AK.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KX2-391 50 mg (Days 1 to 5) | Experimental | Drug: 50 mg of KX2-391 Ointment 1%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. |
| KX2-391 50 mg (Days 1 to 3) | Experimental | Drug: 50 mg of KX2-391 Ointment 1%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females ≥18 years old
- Clinical diagnosis of stable, clinically typical actinic keratosis
- A define treatment area on the face or scalp
- 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
- Males who have not had a vasectomy must agree to use barrier contraception
Key exclusion criteria (10 listed)
- Clinically atypical and/or rapidly changing AK lesions on the treatment area
- 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
- 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
- Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
- Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 mg of KX2-391 Ointment 1%Dose: 50 mg; Route of administration: Topical | Drug | KX2-391 50 mg (Days 1 to 5) |
| 50 mg of KX2-391 Ointment 1%Dose: 50 mg; Route of administration: Topical | Drug | KX2-391 50 mg (Days 1 to 3) |
Primary outcome
Percentage of Participants With Complete Response of Actinic Keratosis
Time frame: Day 57
Complete response rate was defined as the percentage of participants achieving 100% clearance in the treatment area on the face or scalp at Day 57.
13 secondary outcomes
Percentage of Participants With Partial Response of Actinic Keratosis
Time frame: Day 57
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57
Time frame: Baseline, Days 8, 15, 29 and 57
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 57 (Treatment and follow-up period)
Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period
Time frame: From Day 57 up to 12-months post-Day 57 (Recurrence follow-up period)
Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs)
Time frame: Day 57
Number of Participants With Clinically Significant Abnormalities in Laboratory
Time frame: Baseline to Day 57
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Baseline up to Day 57
Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)
Time frame: Baseline up to Day 57
Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE)
Time frame: Baseline up to Day 57
Maximum Observed Plasma Concentration (Cmax) of KX2-391 of KX2-391
Time frame: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Area Under the Plasma Concentration Time Curve From Time 0 to the Last Sampling Time (AUCt) of KX2-391
Time frame: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Minimum Observed Plasma Concentration (Cmin) of KX2-391
Time frame: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Accumulation Ratio (R)
Time frame: Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33196758Kempers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Fang, MD study chair
Kinex Pharmaceuticals Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 50 mg of KX2-391 Ointment 1% in people with Actinic Keratosis, run by Almirall, S.A. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Complete Response of Actinic Keratosis (time frame: Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.