Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03285490
Recruitment Status : Completed
First Posted : September 18, 2017
Results First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
Athenex, Inc.
Information provided by (Responsible Party):
Almirall, S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Actinic Keratosis
Interventions Drug: KX2-391 Ointment 1%
Drug: Placebo
Enrollment 351
Recruitment Details The study was conducted at 31 sites in the United States between 15-September-2017 to 24-April-2019.
Pre-assignment Details A total of 410 participants were screened, of which 351 participants were enrolled, 173 were randomized to vehicle control (118 face, 55 scalp) and 178 to KX2-391 ointment 1 percent (%) (119 face, 59 scalp). This study consisted of 2 periods i.e., Treatment and response assessment period (Baseline up to Day 57) followed by Recurrence follow-up period (12 months post-Day 57).
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 centimeter square (cm^2) on face or scalp. KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Period Title: Treatment and Response Assessment Period
Started 173 178
Completed 173 178
Not Completed 0 0
Period Title: Recurrence Follow-up Period
Started [1] 22 97
Completed 4 36
Not Completed 18 61
Reason Not Completed
Withdrawal by Subject             0             1
AK recurrence during Recurrence Follow-Up Period             18             60
[1]
Number of participants who achieved 100% AK clearance at Day 57 visit had entered the recurrence follow-up period.
Arm/Group Title Placebo KX2-391 Ointment 1% Total
Hide Arm/Group Description Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp. KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp. Total of all reporting groups
Overall Number of Baseline Participants 173 178 351
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 173 participants 178 participants 351 participants
70.2  (8.86) 69.1  (8.69) 69.7  (8.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 178 participants 351 participants
Female
23
  13.3%
20
  11.2%
43
  12.3%
Male
150
  86.7%
158
  88.8%
308
  87.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 178 participants 351 participants
Hispanic or Latino
8
   4.6%
11
   6.2%
19
   5.4%
Not Hispanic or Latino
165
  95.4%
167
  93.8%
332
  94.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 178 participants 351 participants
American Indian or Alaska Native
0
   0.0%
1
   0.6%
1
   0.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
173
 100.0%
177
  99.4%
350
  99.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Number of AK lesions at baseline  
Mean (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 173 participants 178 participants 351 participants
5.8  (1.20) 6.0  (1.27) 5.9  (1.24)
1.Primary Outcome
Title Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions
Hide Description Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 173 178
Measure Type: Number
Unit of Measure: percentage of participants
13 54
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, KX2-391 Ointment 1%
Comments Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value threshold for statistical significance was 0.5%
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57
Hide Description 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.
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 173 178
Measure Type: Number
Unit of Measure: percentage of participants
20 76
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, KX2-391 Ointment 1%
Comments Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value threshold for statistical significance was 0.5%.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57
Hide Description Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp).
Time Frame Days 8, 15, 29 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 173 178
Median (Full Range)
Unit of Measure: lesion count
Day 8 Number Analyzed 170 participants 159 participants
0.0
(-8 to 1)
-1.0
(-7 to 3)
Day 15 Number Analyzed 173 participants 169 participants
-1.0
(-7 to 1)
-4.0
(-8 to 3)
Day 29 Number Analyzed 172 participants 177 participants
-1.0
(-7 to 2)
-5.0
(-8 to 1)
Day 57 Number Analyzed 173 participants 178 participants
-1.0
(-8 to 2)
-5.0
(-8 to 1)
4.Secondary Outcome
Title Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57
Hide Description 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.
Time Frame 3, 6, 9 and 12 months post-Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title KX2-391 Ointment 1%
Hide Arm/Group Description:
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: percentage of participants
3 months post-Day 57 Number Analyzed 96 participants
27
6 months post-Day 57 Number Analyzed 70 participants
31
9 months post-Day 57 Number Analyzed 48 participants
27
12 months post-Day 57 Number Analyzed 35 participants
23
5.Secondary Outcome
Title Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Hide Description 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).
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included participants who received at least one dose of study treatment.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 173 178
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema-Grade 0
79
  45.7%
3
   1.7%
Erythema-Grade 1
81
  46.8%
47
  26.4%
Erythema-Grade 2
13
   7.5%
111
  62.4%
Erythema-Grade 3
0
   0.0%
17
   9.6%
Flaking/Scaling-Grade 0
82
  47.4%
8
   4.5%
Flaking/Scaling-Grade 1
69
  39.9%
60
  33.7%
Flaking/Scaling-Grade 2
21
  12.1%
90
  50.6%
Flaking/Scaling-Grade 3
1
   0.6%
20
  11.2%
Crusting-Grade 0
148
  85.5%
92
  51.7%
Crusting-Grade 1
19
  11.0%
51
  28.7%
Crusting-Grade 2
6
   3.5%
30
  16.9%
Crusting-Grade 3
0
   0.0%
5
   2.8%
Swelling-Grade 0
169
  97.7%
110
  61.8%
Swelling-Grade 1
4
   2.3%
47
  26.4%
Swelling-Grade 2
0
   0.0%
20
  11.2%
Swelling-Grade 3
0
   0.0%
1
   0.6%
Vesiculation/Pustulation-Grade 0
172
  99.4%
166
  93.3%
Vesiculation/Pustulation-Grade 1
1
   0.6%
11
   6.2%
Vesiculation/Pustulation-Grade 2
0
   0.0%
0
   0.0%
Vesiculation/Pustulation-Grade 3
0
   0.0%
1
   0.6%
Erosion/Ulceration-Grade 0
171
  98.8%
156
  87.6%
Erosion/Ulceration-Grade 1
2
   1.2%
18
  10.1%
Erosion/Ulceration-Grade 2
0
   0.0%
4
   2.2%
Erosion/Ulceration-Grade 3
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Pigmentation and Scarring in the Treatment Area
Hide Description Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed.
Time Frame Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 173 178
Measure Type: Count of Participants
Unit of Measure: Participants
Hypopigmentation: Baseline
26
  15.0%
30
  16.9%
Hypopigmentation: Day 5
26
  15.0%
28
  15.7%
Hypopigmentation: Day 8
23
  13.3%
30
  16.9%
Hypopigmentation: Day 15
21
  12.1%
31
  17.4%
Hypopigmentation: Day 29
21
  12.1%
32
  18.0%
Hypopigmentation: Day 57
21
  12.1%
29
  16.3%
Hyperpigmentation: Baseline
33
  19.1%
36
  20.2%
Hyperpigmentation: Day 5
30
  17.3%
33
  18.5%
Hyperpigmentation: Day 8
30
  17.3%
34
  19.1%
Hyperpigmentation: Day 15
27
  15.6%
32
  18.0%
Hyperpigmentation: Day 29
24
  13.9%
29
  16.3%
Hyperpigmentation: Day 57
25
  14.5%
25
  14.0%
Scarring: Baseline
9
   5.2%
11
   6.2%
Scarring: Day 5
8
   4.6%
13
   7.3%
Scarring: Day 8
8
   4.6%
11
   6.2%
Scarring: Day 15
9
   5.2%
9
   5.1%
Scarring: Day 29
8
   4.6%
9
   5.1%
Scarring: Day 57
10
   5.8%
9
   5.1%
7.Secondary Outcome
Title Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests
Hide Description 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.
Time Frame Baseline (Day 1 predose) up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 173 178
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AE
73
  42.2%
71
  39.9%
Participants with any TEAE
67
  38.7%
67
  37.6%
Participants with any SAE
4
   2.3%
1
   0.6%
Participants with events of special interest
4
   2.3%
4
   2.2%
8.Secondary Outcome
Title 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
Hide Description 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.
Time Frame From Day 57 up to 12-months post-Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Recurrence follow-up population included all participants in the ITT Population who achieved complete clearance at the Day 57 visit.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 22 97
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with any AE
0
   0.0%
2
   2.1%
Participants with any SAE
0
   0.0%
0
   0.0%
Participants with events of special interest
1
   4.5%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis
Hide Description Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator.
Time Frame From Baseline (Day 1 predose) up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 173 178
Measure Type: Count of Participants
Unit of Measure: Participants
Hematology
0
   0.0%
0
   0.0%
Blood chemistry
4
   2.3%
0
   0.0%
Urinalysis
0
   0.0%
1
   0.6%
10.Secondary Outcome
Title Number of Participants With Clinically Significant Safety Observations- Vital Signs
Hide Description Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Time Frame From Baseline (Day 1 predose) up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 173 178
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Clinically Significant Safety Observations- Physical Examination
Hide Description A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
Time Frame From Baseline (Day 1 predose) up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 173 178
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs)
Hide Description ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator.
Time Frame From Baseline (Day 1 predose) up to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description:
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
Overall Number of Participants Analyzed 173 178
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Adverse Event Reporting Description Safety population included all randomized participants who received at least one dose of study treatment.
 
Arm/Group Title Placebo KX2-391 Ointment 1%
Hide Arm/Group Description Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp. KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm^2 on face or scalp.
All-Cause Mortality
Placebo KX2-391 Ointment 1%
Affected / at Risk (%) Affected / at Risk (%)
Total   0/173 (0.00%)      0/178 (0.00%)    
Hide Serious Adverse Events
Placebo KX2-391 Ointment 1%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/173 (2.31%)      1/178 (0.56%)    
Cardiac disorders     
Atrioventricular block complete * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
General disorders     
Chest pain * 1  1/173 (0.58%)  1 1/178 (0.56%)  1
Infections and infestations     
Bacteraemia * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Intervertebral disc degeneration * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo KX2-391 Ointment 1%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   72/173 (41.62%)      72/178 (40.45%)    
Blood and lymphatic system disorders     
Lymphadenopathy * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Cardiac disorders     
Arrhythmia * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Atrial flutter * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Tachycardia * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Eye disorders     
Diplopia * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea * 1  1/173 (0.58%)  1 1/178 (0.56%)  1
Bowel movement irregularity * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Food poisoning * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Inguinal hernia * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Haemorrhoids * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Tongue disorder * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
General disorders     
Application site pruritus * 1  13/173 (7.51%)  13 19/178 (10.67%)  19
Application site pain * 1  5/173 (2.89%)  5 24/178 (13.48%)  31
Application site inflammation * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Application site nodule * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Application site paraesthesia * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Application site scab * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Chest discomfort * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Influenza like illness * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Nodule * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Non-cardiac chest pain * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Peripheral swelling * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Immune system disorders     
Seasonal allergy * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Infections and infestations     
Upper respiratory tract infection * 1  10/173 (5.78%)  10 8/178 (4.49%)  8
Viral upper respiratory tract infection * 1  4/173 (2.31%)  4 9/178 (5.06%)  9
Cellulitis * 1  1/173 (0.58%)  1 2/178 (1.12%)  2
Sinusitis * 1  3/173 (1.73%)  3 0/178 (0.00%)  0
Urinary tract infection * 1  3/173 (1.73%)  3 1/178 (0.56%)  1
Influenza * 1  2/173 (1.16%)  2 1/178 (0.56%)  1
Angular cheilitis * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Application site folliculitis * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Bronchitis * 1  1/173 (0.58%)  1 1/178 (0.56%)  1
Carbuncle * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Gastroenteritis viral * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Herpes simplex * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Labyrinthitis * 1  2/173 (1.16%)  2 0/178 (0.00%)  0
Localised infection * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Onychomycosis * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Post procedural infection * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Postoperative wound infection * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Pyuria * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Streptococcal infection * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Subcutaneous abscess * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Tooth infection * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Bacteriuria * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Injury, poisoning and procedural complications     
Skin abrasion * 1  3/173 (1.73%)  4 4/178 (2.25%)  4
Animal bite * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Arthropod bite * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Concussion * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Contusion * 1  2/173 (1.16%)  2 1/178 (0.56%)  1
Face injury * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Fall * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Laceration * 1  0/173 (0.00%)  0 1/178 (0.56%)  2
Ligament sprain * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Tooth fracture * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Investigations     
Alanine aminotransferase increased * 1  2/173 (1.16%)  2 0/178 (0.00%)  0
Aspartate aminotransferase increased * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Blood testosterone decreased * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Cardiac murmur * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Crystal urine present * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Prostatic specific antigen increased * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Urobilinogen urine increased * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Metabolism and nutrition disorders     
Haemochromatosis * 1  0/173 (0.00%)  0 2/178 (1.12%)  2
Hyperkalaemia * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/173 (0.58%)  1 2/178 (1.12%)  2
Arthralgia * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Intervertebral disc degeneration * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Myalgia * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma * 1  4/173 (2.31%)  5 3/178 (1.69%)  3
Basal cell carcinoma * 1  3/173 (1.73%)  3 3/178 (1.69%)  4
Haemangioma of skin * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Malignant melanoma in situ * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Melanocytic naevus * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Neoplasm * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Renal cancer recurrent * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Seborrhoeic keratosis * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Skin papilloma * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Squamous cell carcinoma of head and neck * 1  3/173 (1.73%)  3 0/178 (0.00%)  0
Colon cancer * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Nervous system disorders     
Headache * 1  2/173 (1.16%)  2 1/178 (0.56%)  1
Dysgeusia * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Hypoaesthesia * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Nervous system disorder * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Dizziness * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Renal and urinary disorders     
Ketonuria * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Glycosuria * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Proteinuria * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  3/173 (1.73%)  3 1/178 (0.56%)  1
Chronic obstructive pulmonary disease * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Dyspnoea * 1  2/173 (1.16%)  2 0/178 (0.00%)  0
Nasal congestion * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Oropharyngeal pain * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Sinus congestion * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Pulmonary embolism * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Skin and subcutaneous tissue disorders     
Dermatitis * 1  1/173 (0.58%)  1 1/178 (0.56%)  1
Actinic keratosis * 1  0/173 (0.00%)  0 2/178 (1.12%)  5
Blister * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Dermatitis contact * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Erythema * 1  0/173 (0.00%)  0 2/178 (1.12%)  2
Lentigo * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Rosacea * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Scab * 1  1/173 (0.58%)  1 1/178 (0.56%)  1
Skin tightness * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Urticaria * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Skin ulcer * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Surgical and medical procedures     
Arthrodesis * 1  0/173 (0.00%)  0 1/178 (0.56%)  1
Meniscus operation * 1  1/173 (0.58%)  1 0/178 (0.00%)  0
Vascular disorders     
Hypertension * 1  1/173 (0.58%)  1 1/178 (0.56%)  1
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Global Clinical Development
Organization: Almirall S.A.
Phone: +34932913000
EMail: rd@almirall.com
Layout table for additonal information
Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT03285490    
Other Study ID Numbers: KX01-AK-004
U1111-1191-8287 ( Other Identifier: UTN )
First Submitted: September 7, 2017
First Posted: September 18, 2017
Results First Submitted: February 16, 2021
Results First Posted: March 10, 2021
Last Update Posted: March 10, 2021