Trial · NCT03285490
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
NCT03285490, Phase 3, Completed, Almirall, S.A.; results first posted 2021-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004). Trials, record NCT03285490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03285490
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
- NCT number
- NCT03285490
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 351 participants, actual
- Lead sponsor
- Almirall, S.A.
- Conditions
- Actinic Keratosis
- Interventions
- KX2-391 Ointment 1%, Placebo
- First posted
- 2017-09-18
- Last updated
- 2021-03-10
- Results first posted
- 2021-03-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions | Day 57 | Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area. |
| Secondary | Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57 | Day 57 | Partial clearance rate of AK lesions was defined as the percentage of participants with a greater than or equal to (\>=) 75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the treatment area. |
| Secondary | Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 | Days 8, 15, 29 and 57 | Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp). |
| Secondary | Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57 | 3, 6, 9 and 12 months post-Day 57 | Recurrence rate was estimated based on Kaplan-Meier method, with recurrence define as appearance of any AK lesions in the treatment area, including those recurred or newly identified. |
| Secondary | Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR) | Day 57 | Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. The LSR assessment was an Investigator's (or sub-investigator's) assessment of the following signs on the treatment area: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. The LSRs were graded on a 4-point scale ranging from 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). |
| Secondary | Number of Participants With Pigmentation and Scarring in the Treatment Area | Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57 | Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed. |
| Secondary | Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests | Baseline (Day 1 predose) up to Day 57 | An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. TEAEs (serious and non-serious) were defined as either those AEs with onset after first dose or those pre-existing AEs that worsen after first dose. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy. |
| Secondary | Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57 | From Day 57 up to 12-months post-Day 57 | An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy. |
| Secondary | Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis | From Baseline (Day 1 predose) up to Day 57 | Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator. |
| Secondary | Number of Participants With Clinically Significant Safety Observations- Vital Signs | From Baseline (Day 1 predose) up to Day 57 | Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions | Day 57 | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57 | Day 57 | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 | Days 8, 15, 29 and 57 | ITT population included all randomized participants. | lesion count | MEDIAN |
| SECONDARY | Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57 | 3, 6, 9 and 12 months post-Day 57 | Recurrence follow-up population included all participants in the ITT Population who achieved complete clearance at the Day 57 visit. The recurrence rate was evaluated only for KX2-391 Ointment 1% arm, pre-specified in protocol. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR) | Day 57 | Safety analysis set included participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Pigmentation and Scarring in the Treatment Area | Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57 | Safety Population included all randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests | Baseline (Day 1 predose) up to Day 57 | Safety Population included all randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57 | From Day 57 up to 12-months post-Day 57 | Recurrence follow-up population included all participants in the ITT Population who achieved complete clearance at the Day 57 visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis | From Baseline (Day 1 predose) up to Day 57 | Safety Population included all randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Safety Observations- Vital Signs | From Baseline (Day 1 predose) up to Day 57 | Safety Population included all randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions | Placebo | 13 | percentage of participants | ||
| Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions | KX2-391 Ointment 1% | 54 | percentage of participants | ||
| Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57 | Placebo | 20 | percentage of participants | ||
| Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57 | KX2-391 Ointment 1% | 76 | percentage of participants | ||
| Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 | Placebo | Day 8 | 0.0 | Full Range -8 to 1 | lesion count |
| Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 | KX2-391 Ointment 1% | Day 8 | -1.0 | Full Range -7 to 3 | lesion count |
| Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 | Placebo | Day 15 | -1.0 | Full Range -7 to 1 | lesion count |
| Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 | KX2-391 Ointment 1% | Day 15 | -4.0 | Full Range -8 to 3 | lesion count |
| Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 | Placebo | Day 29 | -1.0 | Full Range -7 to 2 | lesion count |
| Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 | KX2-391 Ointment 1% | Day 29 | -5.0 | Full Range -8 to 1 | lesion count |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment and Response Assessment Period | STARTED | Placebo | 173 | |
| Treatment and Response Assessment Period | STARTED | KX2-391 Ointment 1% | 178 | |
| Treatment and Response Assessment Period | COMPLETED | Placebo | 173 | |
| Treatment and Response Assessment Period | COMPLETED | KX2-391 Ointment 1% | 178 | |
| Treatment and Response Assessment Period | NOT COMPLETED | Placebo | 0 | |
| Treatment and Response Assessment Period | NOT COMPLETED | KX2-391 Ointment 1% | 0 | |
| Recurrence Follow-up Period | STARTED | Placebo | 22 | |
| Recurrence Follow-up Period | STARTED | KX2-391 Ointment 1% | 97 | |
| Recurrence Follow-up Period | COMPLETED | Placebo | 4 | |
| Recurrence Follow-up Period | COMPLETED | KX2-391 Ointment 1% | 36 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events228
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 1 | 173 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | KX2-391 Ointment 1% | 0 | 178 | 0 |
| other | Arrhythmia | Cardiac disorders | Placebo | 0 | 173 | 0 |
| other | Arrhythmia | Cardiac disorders | KX2-391 Ointment 1% | 1 | 178 | 1 |
| other | Atrial flutter | Cardiac disorders | Placebo | 1 | 173 | 1 |
| other | Atrial flutter | Cardiac disorders | KX2-391 Ointment 1% | 0 | 178 | 0 |
| other | Tachycardia | Cardiac disorders | Placebo | 1 | 173 | 1 |
| other | Tachycardia | Cardiac disorders | KX2-391 Ointment 1% | 0 | 178 | 0 |
| other | Diplopia | Eye disorders | Placebo | 1 | 173 | 1 |
| other | Diplopia | Eye disorders | KX2-391 Ointment 1% | 0 | 178 | 0 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 173 |
| Total, all-cause mortality | KX2-391 Ointment 1% | 0 | 178 |
| Total, other adverse events | Placebo | 72 | 173 |
| Total, other adverse events | KX2-391 Ointment 1% | 72 | 178 |
| Total, serious adverse events | Placebo | 4 | 173 |
| Total, serious adverse events | KX2-391 Ointment 1% | 1 | 178 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33567191 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| KX2-391 Ointment 1% vs Placebo: Number of Participants With Clinically Significant Safety Observations- Physical Examination | Trial comparisons |
| KX2-391 Ointment 1% vs Placebo: Number of Participants With Clinically Significant Safety Observations- Vital Signs | Trial comparisons |
| KX2-391 Ointment 1% vs Placebo: deaths from any cause | Trial comparisons |
| KX2-391 Ointment 1% vs Placebo: Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs) | Trial comparisons |
| KX2-391 Ointment 1% vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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