Actinic KeratosesPhase 1NCT03575780
Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis
A Phase 1 study testing KX2-391 Ointment 1% in people with Actinic Keratoses, run by Athenex, Inc. at 1 site in United States.
Trial summary
This Phase I study is designed to evaluate the systemic exposure and safety of KX2-391 Ointment in adult subjects when applied to an area of skin containing at least 5 clinically typical, visible, and discrete Actinic Keratosis lesions on the face or balding scalp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- KX2-391 Ointment 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 10 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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.
- Able to comprehend and are willing to sign an informed consent form (ICF).
- At least 5 clinically typical, visible, and discrete AKs on 25 cm2 of the face or balding scalp.
- Subjects who, in the judgment of the Investigator, are in good general health based on:
- Medical history
- Physical examination (PE) findings
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- ECG, clinical chemistry, hematology, and urinalysis results.
- In the case of a female of childbearing potential, TKL will initiate two forms of birth control at Screening and that at least one had to be in place for 30 days prior (oral/implant/injectable/transdermal contraceptives, intrauterine device (IUD), condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
- Females of childbearing potential, must agree to continue to use two methods of birth control for 30 days following the last dose of study treatment;
- In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
- In the case of sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment;
- In the case of a female of non-childbearing potential, has had a hysterectomy or is postmenopausal (at least 2 years with no menses prior to enrollment);
- All subjects must agree not to donate sperm or eggs or attempt conception from Screening through 90 days following their last dose of study treatment;
- Willing to avoid direct sun or ultraviolet (UV) light exposure to the face or scalp.
Who cannot join
- Clinically atypical and/or rapidly changing AK lesions on the treatment area, e.g., hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on two previous occasions) and/or cutaneous horn.
- Location of the treatment area:
- Within 5 cm of an incompletely healed wound
- Within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
- Been previously treated with KX2-391 ointment.
- Has QTcF >450 ms for males and 470 ms for females or other relevant pathological changes in the ECG, in the opinion of the Investigation, at Screening.
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- Anticipated need for in-patient hospitalization or in-patient surgery during the study.
- Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within 2 cm of the treatment area, within 8 weeks prior to the Screening visit.
- Use of the following therapies and/or medications within 2 weeks prior to the Screening visit:
- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within 2 cm of the selected treatment area
- Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within 2 cm of the selected treatment area
- Topical salves (non-medicated/non-irritant lotion and cream are acceptable) or topical steroids within 2 cm of the selected treatment area; artificial tanners within 5 cm of the selected treatment area.
- Use of the following therapies and/or medications within 4 weeks prior to the Screening visit:
- Treatment with immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon inducers
- Treatment with systemic medications that suppress the immune system (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab)
- Therapy/treatment with UVA or UVB.
- Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit.
- A history of sensitivity and/or allergy to any of the ingredients in the study medication.
- A skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the subject to unacceptable risk by study participation.
- Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would exposure the subject 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 30 days or 5 half-lives or the investigational product, whichever is longer, before dosing.
Trial locations and contacts
1 site in 1 country.
About this study
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
This Phase I study is designed to evaluate the systemic exposure and safety of KX2-391 Ointment in adult subjects when applied to an area of skin containing at least 5 clinically typical, visible, and discrete Actinic Keratosis lesions on the face or balding scalp.
Read the detailed description
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.
- Conditions
- Actinic Keratoses
- Being tested
- 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.
KX2-391 Ointment 1%Drug
The experimental drug, KX2-391 Ointment 1% will be used in subjects with Clinically typical Actinic Keratosis on the face or balding scalp.
| Study group | Role | What they receive |
|---|---|---|
| KX2-391 Ointment | Experimental | KX2-391 ointment 1% will be administered once daily over 5 consecutive days Receives: Drug: KX2-391 Ointment 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of KX2-391 Ointment in the blood stream
The measurement of KX2-391 Ointment levels in the blood stream over time
Measured: 6 Days
Secondary outcomes (3)
Local Skin Reactions
To evaluate the safety of KX2-391 Ointment 1% by the proportion and severity of local skin reactions
Measured: 29 Days
Adverse Events
To evaluate the safety of KX2-391 Ointment 1% by the proportion of adverse events
Measured: 29 Days
Abnormal Laboratory Assessments
To evaluate the safety of KX2-391 Ointment 1% by the proportion of abnormal laboratory assessments
Measured: 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start7 Sep 2018
- Primary completion25 Apr 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will test KX2-391 Ointment 1%.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Responsible party
- Sponsor
- Investigators
- David Cutler, MD, FRCP, Study chair, Athenex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575780
- Sponsor's protocol ID
- KX01-AK-007
- Status last verified
- Dec 2019
- First submitted
- 7 Jun 2018
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03575780
- Acronym / sponsor ID
- KX01-AK-007
- Conditions
- Actinic Keratoses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I study is designed to evaluate the systemic exposure and safety of KX2-391 Ointment in adult subjects when applied to an area of skin containing at least 5 clinically typical, visible, and discrete Actinic Keratosis lesions on the face or balding scalp.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will test KX2-391 Ointment 1%.
| Arm | Type | Receives |
|---|---|---|
| KX2-391 Ointment | Experimental | Drug: KX2-391 Ointment 1%KX2-391 ointment 1% will be administered once daily over 5 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males and females ≥18 years old.
- Able to comprehend and are willing to sign an informed consent form (ICF).
- At least 5 clinically typical, visible, and discrete AKs on 25 cm2 of the face or balding scalp.
- Subjects who, in the judgment of the Investigator, are in good general health based on:
- In the case of a female of childbearing potential, TKL will initiate two forms of birth control at Screening and that at least one had to be in place for 30 days prior (oral/implant/injectable/transdermal contraceptives, intrauterine device (IUD), condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
Key exclusion criteria (22 listed)
- Clinically atypical and/or rapidly changing AK lesions on the treatment area, e.g., hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on two previous occasions) and/or cutaneous horn.
- Location of the treatment area:
- Been previously treated with KX2-391 ointment.
- Has QTcF >450 ms for males and 470 ms for females or other relevant pathological changes in the ECG, in the opinion of the Investigation, at Screening.
- Anticipated need for in-patient hospitalization or in-patient surgery during the study.
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 |
|---|---|---|
| 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. | Drug | KX2-391 Ointment |
Primary outcome
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
3 secondary outcomes
Local Skin Reactions
Time frame: 29 Days
Adverse Events
Time frame: 29 Days
Abnormal Laboratory Assessments
Time frame: 29 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
David Cutler, MD, FRCP study chair
Athenex, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KX2-391 Ointment 1% in people with Actinic Keratoses, run by Athenex, Inc. at 1 site 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 14 inclusion and 22 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 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of KX2-391 Ointment in the blood stream (time frame: 6 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2019.