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

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ClinicalTrials.gov Identifier: NCT05231044
Recruitment Status : Active, not recruiting
First Posted : February 9, 2022
Last Update Posted : February 9, 2022
Sponsor:
Collaborator:
PharmaEssentia Japan K.K.
Information provided by (Responsible Party):
PharmaEssentia

Brief 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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: KX01 ointment 1% Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study tests KX01 Ointment 1% against a placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 21, 2021
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Arm Intervention/treatment
Experimental: KX01 Ointment 1%
KX01 Ointment 1% is applied topically once daily for 5 consecutive days on face or scalp
Drug: KX01 ointment 1%
The experimental drug, KX01 Ointment 1% is used in participants with Clinically typical AK on the face or scalp.

Placebo Comparator: Placebo
Vehicle Ointment is applied topically once daily for 5 consecutive days on face or scalp
Drug: Placebo
Vehicle Ointment is used in participants with Clinically typical AK on the face or scalp.




Primary Outcome Measures :
  1. Percentage of participants with complete (100%) clearance of Actinic Keratosis (AK) lesions [ Time Frame: Day 57 ]
    Complete clearance rate is defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.


Secondary Outcome Measures :
  1. Partial Clearance Rate of AK Lesions at Day 57 [ Time Frame: 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.

  2. Recurrence rate of AK lesions in subjects who achieved complete clearance at Day 57 [ Time Frame: 3, 6, 9 and 12 months post-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.

  3. Number of participants with local skin reactions (LSR) in the treatment area [ Time Frame: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57 ]
    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.

  4. Number of participants with pigmentation and scarring in the treatment area [ Time Frame: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57 ]
    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.

  5. Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs), events of special interest [ Time Frame: 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 [ Time Frame: After Day 57 up to 12 months post-Day 57 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Japanese Males and females ≥20 years old
  2. A treatment area on the face or scalp that:

    1. is a contiguous area measured 25 cm2
    2. contains more than 1 clinically typical, visible, and discrete AK lesions
  3. Subjects who, in the judgment of the Investigator or Sub-investigator, are in good general health based on:

    1. medical history
    2. physical examination (PE) findings
    3. vital signs
    4. clinical chemistry, hematology, and urinalysis results
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp

Exclusion Criteria:

  1. 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
  2. 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
  3. Been previously treated with KX01 Ointment
  4. Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57
  5. 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
  6. 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
  7. 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

Information from the National Library of Medicine

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): NCT05231044


Locations
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Sponsors and Collaborators
PharmaEssentia
PharmaEssentia Japan K.K.
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Responsible Party: PharmaEssentia
ClinicalTrials.gov Identifier: NCT05231044    
Other Study ID Numbers: B21-301
First Posted: February 9, 2022    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PharmaEssentia:
Actinic Keratosis
Skin disease
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms