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Actinic KeratosisPhase 3NCT05231044

A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp

A Phase 3 study testing KX01 ointment 1% in people with Actinic Keratosis, run by PharmaEssentia at 20 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase III study is designed to evaluate the efficacy and safety of KX01 Ointment in adult participants when applied to an area of skin containing more than 1, clinically typical Actinic Keratosis (AK) lesions on the face or scalp. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Actinic Keratosis
What is being tested?
KX01 ointment 1%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
20 sitesJapan
Study dates
21 Dec 2021to 20 Nov 2023
Phase
Phase 3
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Japanese Males and females ≥20 years old
  • A treatment area on the face or scalp that:
  • is a contiguous area measured 25 cm2
  • contains more than 1 clinically typical, visible, and discrete AK lesions
  • Subjects who, in the judgment of the Investigator or Sub-investigator, are in good general health based on:
  • medical history
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  • physical examination (PE) findings
  • vital signs
  • clinical chemistry, hematology, and urinalysis results
  • Females must be postmenopausal (>45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, women with childbearing potential must use highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device, or complete abstinence from sexual intercourse.
  • Sexually active males who have not had a vasectomy and whose partner is reproductively capable must agree to use barrier contraception from Screening until 90 days after their last dose of study treatment.
  • All subjects must agree not to donate sperm or eggs or attempt conception from Screening until 90 days following their last dose of study treatment.
  • Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to randomization.
  • Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, 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 is:
  • On any location other than the face or scalp
  • Within 5 cm of an incompletely healed wound
  • Within 5 cm of a suspected basal cell carcinoma (BCC) or SCC
  • Been previously treated with KX01 Ointment
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  • Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57
  • Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or 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 the treatment area or 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 the treatment area or within 2 cm of the selected treatment area
  • Topical salves (non-medicated / non-irritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Japan20 sites

  • Toho University Medical Center Sakura Hospital

    Chiba

  • Kiryu Dermatology Clinic

    Fukuoka

  • Tomoko Matsuda dermatology Clinic

    Fukuoka

  • Takamatsu Red Cross Hospital

    Kagawa

  • Hashiguchi Dermatology

    Kagoshima

  • Katahira Dermatology and Urology

    Kagoshima

  • National Hospital Organization Sagamihara National Hospital

    Kanagawa

  • Nippon Medical School Musashi Kosugi Hospital

    Kanagawa

  • Kumamoto University Hospital

    Kumamoto

  • Noguchi Dermatology Clinic

    Kumamoto

  • Suizenji Dermatology Clinic

    Kumamoto

  • Futaba Dermatology and Skin Surgery Clinic

    Miyazaki

  • Toyama Hifuka

    Miyazaki

  • Okayama Saiseikai Outpatient Center Hospital

    Okayama

  • Medical Corporation Ayumi Sakurakai Dermatology Ophthalmology Kume Clinic

    Osaka

  • Mochidahifuka

    Osaka

  • Juntendo University Hospital

    Tokyo

  • NTT Medical Center Tokyo

    Tokyo

  • Toyama Prefectural Central Hospital

    Toyama

  • University of Yamanashi Hospital

    Yamanashi

Other trials in Japan

About this study

Official title: A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy, Safety and PK Study of KX01 Ointment 1% in Japanese Adult Subjects With Actinic Keratosis on the Face or Scalp

This Phase III study is designed to evaluate the efficacy and safety of KX01 Ointment in adult participants when applied to an area of skin containing more than 1, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.

Read the detailed description

This study is a double-blinded, multicenter, activity, and safety study of KX01 Ointment administered topically to the face or scalp of participants with actinic keratosis. The study consists of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received 5 consecutive days of topical treatment, to be applied at the study site. Activity (lesion counts) and safety evaluations is performed.

Being tested
KX01 ointment 1%, Placebo
Keywords
Actinic Keratosis, Skin disease
Medical subject headings
Keratosis, Actinic, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KX01 ointment 1%Drug

    The experimental drug, KX01 Ointment 1% is used in participants with Clinically typical AK on the face or scalp.

  • PlaceboDrug

    Vehicle Ointment is used in participants with Clinically typical AK on the face or scalp.

Study groups in NCT05231044
Study groupRoleWhat they receive
KX01 Ointment 1%ExperimentalKX01 Ointment 1% is applied topically once daily for 5 consecutive days on face or scalp
Receives: Drug: KX01 ointment 1%
PlaceboPlacebo comparatorVehicle Ointment is applied topically once daily for 5 consecutive days on face or scalp
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with complete (100%) clearance of Actinic Keratosis (AK) lesions

    Complete clearance rate is defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.

    Measured: Day 57

Secondary outcomes (6)

  1. Partial Clearance Rate of AK Lesions at Day 57

    Partial clearance rate of AK lesions is defined as the proportion of subjects on Day 57 with a ≥ 75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the treatment area.

    Measured: Day 57

  2. Recurrence rate of AK lesions in subjects who achieved complete clearance at Day 57

    For subjects who achieve 100% clearance of AK lesions in the treatment area on Day 57, a Investigator or Sub-investigator will perform a count of clinically visible AK lesions (lesion count) during the Recurrence Follow-up Period at the 3-, 6-, 9- and 12-month visits. In principle, the Investigator or Sub-investigator performing the lesion count should be the same Investigator or Sub-investigator who evaluated the subject previously during the study.

    Measured: 3, 6, 9 and 12 months post-Day 57

  3. Number of participants with local skin reactions (LSR) in the treatment area

    At Baseline (Day 1 predose), LSRs on the treatment area will be assessed by the Investigator or Sub-investigator. The same Investigator or Sub-investigator will conduct the LSR assessment at all visits for an individual subject. LSR signs on the treatment area include the following: erythema, flaking / scaling, crusting, swelling, vesiculation / pustulation, and erosion / ulceration. These signs will be assessed using a 4-point grading scale.

    Measured: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57

  4. Number of participants with pigmentation and scarring in the treatment area

    At the time of LSR assessment, hypo- and hyper-pigmentation and scarring on the treatment area will be assessed by the Investigator or Sub-investigator as being present or absent. Pigmentation and scarring will be assessed at Baseline (Day 1 predose). In principle, the same Investigator or Sub-investigator will assess pigmentation and scarring at all visits for an individual subject.

    Measured: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57

  5. Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs), events of special interest

    Measured: From Baseline (Day 1 predose) up to Day 57

  6. Number of participants with AEs within the treatment area after Day 57 up to 12 months post-Day 57

    Measured: After Day 57 up to 12 months post-Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2022
  2. Study start21 Dec 2021
  3. Primary completion20 Nov 2023
  4. Study completion20 Nov 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study tests KX01 Ointment 1% against a placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05231044
Sponsor's protocol ID
B21-301
Status last verified
Apr 2024
First submitted
28 Jan 2022
Last updated
19 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KX01 ointment 1% in people with Actinic Keratosis, run by PharmaEssentia at 20 sites in Japan.

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 14 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Japan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Percentage of participants with complete (100%) clearance of Actinic Keratosis (AK) lesions (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 NCT05231044.

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 19 Apr 2024.

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