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
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratosis||Drug: KX01 ointment 1% Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study tests KX01 Ointment 1% against a placebo.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
Vehicle Ointment is used in participants with Clinically typical AK on the face or scalp.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 ]
- 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 ]
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