Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02404389
Collaborator
(none)
82
10
5
10.8
8.2
0.8
Study Details
Study Description
Brief Summary
This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Topical LFX453 Formulations in Patients With Actinic Keratosis
Actual Study Start Date
:
Mar 5, 2015
Actual Primary Completion Date
:
Jan 27, 2016
Actual Study Completion Date
:
Jan 27, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LFX453 0.1% NMC LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications |
Drug: Investigational Treatment
Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.
|
| Experimental: LFX453 0.15% LCC LFX453 0.15% liquid crystal cream (LCC) Twice daily applications |
Drug: Investigational Treatment
Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.
|
| Placebo Comparator: Vehicle to NMC Vehicle to nanomedicinal cream (NMC) Twice daily applications |
Drug: Investigational Treatment
Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.
|
| Placebo Comparator: Vehicle to LCC Vehicle to liquid crystal cream (LCC) Twice daily applications |
Drug: Investigational Treatment
Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.
|
| Active Comparator: Aldara Aldara cream 3 applications per week |
Drug: Active comparator
Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks [20 weeks]
Number of participants with at least one AE/SAE in the category up to 20 weeks
- Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined [Week 20]
Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
- Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined [Baseline, Week 20]
Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
Secondary Outcome Measures
- Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined [week 8, week 16]
Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined
- Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined [Week 20]
Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined
- Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined [week 8, week 16]
Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined
- Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined [Baseline, Week 8]
Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Male patients, and female patients of non-childbearing potential, age ≥ 18 to ≤ 75 years (at the time of the screening visit), and in general good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
-
Patients with at least five clinically typical, visible or palpable non-hyperkeratotic AK lesions within a contiguous area of 25 cm2, or within 2 areas for a maximum total of 25cm2, on the face (at least 2 cm from the periocular areas, lips, nares and ears) and/or balding scalp
-
Presence of at least one additional visible or palpable non hyperkeratotic AK lesion outside of the selected area amenable to the collection of a skin biopsy, and located at least at 2 cm from the limits of the area to receive treatment
-
Male patients had to agree to use adequate contraception for the duration of the study.
Key Exclusion Criteria:
-
Known hypersensitivity to any constituents of the study drugs (including local anesthetics if consenting to biopsies) or known allergies to imiquimod or to drugs of similar chemical classes or history of serious allergic reaction.
-
Presence of atopic dermatitis, eczema, psoriasis, rosacea or other possible confounding skin conditions on face or balding scalp even outside of the treatment area.
-
Invasive tumors within the treatment area, e.g., merkel cell carcinoma, melanoma, squamous cell carcinoma (SCC), basal cell carcinoma, the latter being accepted if completely surgically removed.
-
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
-
History of hypertrophic scarring.
-
Concurrent disease that suppresses the immune system.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Vienna | Austria | 1040 | |
| 2 | Novartis Investigative Site | Copenhagen NV | Denmark | DK-2400 | |
| 3 | Novartis Investigative Site | Berlin | Germany | 10098 | |
| 4 | Novartis Investigative Site | Berlin | Germany | 10117 | |
| 5 | Novartis Investigative Site | Bonn | Germany | 53111 | |
| 6 | Novartis Investigative Site | Dresden | Germany | 01307 | |
| 7 | Novartis Investigative Site | Frankfurt | Germany | 60590 | |
| 8 | Novartis Investigative Site | Hamburg | Germany | 20354 | |
| 9 | Novartis Investigative Site | Kopavogur | Iceland | 201 | |
| 10 | Novartis Investigative Site | London | United Kingdom | E1 1BB |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02404389
Other Study ID Numbers:
- CLFX453X2201
First Posted:
Mar 31, 2015
Last Update Posted:
Jan 5, 2021
Last Verified:
Mar 1, 2019
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 82 patients, male and female of non-childbearing potential aged 18-75 years, with Actinic Keratosis (AK) on the face or balding scalp were enrolled in the study. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | LFX453 0.1% NMC | LFX453 0.15% LCC | Vehicle to NMC | Vehicle to LCC | Aldara |
|---|---|---|---|---|---|
| Arm/Group Description | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | Vehicle to nanomedicinal cream (NMC) Twice daily applications | Vehicle to liquid crystal cream (LCC) Twice daily applications | Aldara cream 3 applications per week |
| Period Title: Overall Study | |||||
| STARTED | 20 | 20 | 11 | 10 | 21 |
| COMPLETED | 18 | 20 | 10 | 9 | 18 |
| NOT COMPLETED | 2 | 0 | 1 | 1 | 3 |
Baseline Characteristics
| Arm/Group Title | LFX453 0.1% NMC | LFX453 0.15% LCC | Vehicle to NMC | Vehicle to LCC | Aldara | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | Vehicle to nanomedicinal cream (NMC) Twice daily applications | Vehicle to liquid crystal cream (LCC) Twice daily applications | Aldara cream 3 applications per week | Total of all reporting groups |
| Overall Participants | 20 | 20 | 11 | 10 | 21 | 82 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
67.7
(5.23)
|
68.6
(6.25)
|
68.3
(6.66)
|
70.2
(4.32)
|
68.6
(5.61)
|
68.5
(5.61)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
5
25%
|
2
10%
|
0
0%
|
2
20%
|
0
0%
|
9
11%
|
| Male |
15
75%
|
18
90%
|
11
100%
|
8
80%
|
21
100%
|
73
89%
|
Outcome Measures
| Title | Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks |
|---|---|
| Description | Number of participants with at least one AE/SAE in the category up to 20 weeks |
| Time Frame | 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all patients that received any study drug. For Safety & Tolerability only the 2 vehicles have separate analysis. |
| Arm/Group Title | LFX453 0.1% NMC | LFX453 0.15% LCC | Vehicle to NMC | Vehicle to LCC | Aldara |
|---|---|---|---|---|---|
| Arm/Group Description | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | Vehicle to nanomedicinal cream (NMC) Twice daily applications | Vehicle to liquid crystal cream (LCC) Twice daily applications | Aldara cream 3 applications per week |
| Measure Participants | 20 | 20 | 11 | 10 | 21 |
| Adverse Events (AEs) |
10
50%
|
15
75%
|
9
81.8%
|
8
80%
|
18
85.7%
|
| Serious Adverse Events (SAEs) |
1
5%
|
1
5%
|
1
9.1%
|
1
10%
|
1
4.8%
|
| Title | Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined |
|---|---|
| Description | Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined |
| Time Frame | Week 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. |
| Arm/Group Title | LFX453 0.1% NMC | LFX453 0.15% LCC | Combined Vehicle | Aldara |
|---|---|---|---|---|
| Arm/Group Description | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications | Aldara cream 3 applications per week |
| Measure Participants | 20 | 20 | 21 | 21 |
| Number [participants] |
1
5%
|
1
5%
|
1
9.1%
|
13
130%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | LFX453 0.1% NMC, Vehicle to NMC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
| Comments | p value is provided | |
| Statistical Test of Hypothesis | p-Value | 0.515 |
| Comments | ||
| Method | Posterior mean | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 90% -0.12 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | LFX453 0.15% LCC, Vehicle to NMC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
| Comments | p value is provided | |
| Statistical Test of Hypothesis | p-Value | 0.517 |
| Comments | ||
| Method | posterior mean | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 90% -0.12 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 0.07 |
|
| Estimation Comments | ||
| Title | Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined |
|---|---|
| Description | Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined |
| Time Frame | week 8, week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. |
| Arm/Group Title | LFX453 0.1% NMC | LFX453 0.15% LCC | Combined Vehicle | Aldara |
|---|---|---|---|---|
| Arm/Group Description | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications | Aldara cream 3 applications per week |
| Measure Participants | 20 | 20 | 21 | 21 |
| Week 8 |
0
0%
|
0
0%
|
1
9.1%
|
3
30%
|
| Week 16 |
1
5%
|
1
5%
|
1
9.1%
|
9
90%
|
| Title | Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined |
|---|---|
| Description | Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined |
| Time Frame | Week 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. |
| Arm/Group Title | LFX453 0.1% NMC | LFX453 0.15% LCC | Combined Vehicle | Aldara |
|---|---|---|---|---|
| Arm/Group Description | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications | Aldara cream 3 applications per week |
| Measure Participants | 20 | 20 | 21 | 21 |
| Number [participants] |
1
5%
|
2
10%
|
2
18.2%
|
16
160%
|
| Title | Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined |
|---|---|
| Description | Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined |
| Time Frame | week 8, week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. |
| Arm/Group Title | LFX453 0.1% NMC | LFX453 0.15% LCC | Combined Vehicle | Aldara |
|---|---|---|---|---|
| Arm/Group Description | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications | Aldara cream 3 applications per week |
| Measure Participants | 20 | 20 | 21 | 21 |
| Week 8 |
1
5%
|
0
0%
|
3
27.3%
|
7
70%
|
| Week 16 |
3
15%
|
4
20%
|
3
27.3%
|
15
150%
|
| Title | Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined |
|---|---|
| Description | Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined |
| Time Frame | Baseline, Week 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. |
| Arm/Group Title | LFX453 0.1% NMC | LFX453 0.15% LCC | Combined Vehicle | Aldara |
|---|---|---|---|---|
| Arm/Group Description | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications | Aldara cream 3 applications per week |
| Measure Participants | 20 | 20 | 21 | 21 |
| Mean (Standard Deviation) [percent change] |
33.2
(31.19)
|
34.5
(33.20)
|
34.3
(33.31)
|
86.7
(23.53)
|
| Title | Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined |
|---|---|
| Description | Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined |
| Time Frame | Baseline, Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. |
| Arm/Group Title | LFX453 0.1% NMC | LFX453 0.15% LCC | Combined Vehicle | Aldara |
|---|---|---|---|---|
| Arm/Group Description | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications | Aldara cream 3 applications per week |
| Measure Participants | 20 | 20 | 21 | 21 |
| Mean (Standard Deviation) [percent change] |
21.9
(36.18)
|
21.9
(28.91)
|
32.3
(33.55)
|
55.8
(36.54)
|
Adverse Events
| Time Frame | 24 weeks | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | LFX453 0.1% NMC | LFX453 0.15% LCC | Vehicle to NMC | Vehicle to LCC | Aldara | |||||
| Arm/Group Description | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | Vehicle to nanomedicinal cream (NMC) Twice daily applications | Vehicle to liquid crystal cream (LCC) Twice daily applications | Aldara cream 3 applications per week | |||||
All Cause Mortality |
||||||||||
| LFX453 0.1% NMC | LFX453 0.15% LCC | Vehicle to NMC | Vehicle to LCC | Aldara | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| LFX453 0.1% NMC | LFX453 0.15% LCC | Vehicle to NMC | Vehicle to LCC | Aldara | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/20 (5%) | 1/20 (5%) | 1/11 (9.1%) | 1/10 (10%) | 1/21 (4.8%) | |||||
| Cardiac disorders | ||||||||||
| ATRIAL FIBRILLATION | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| ABDOMINAL HERNIA | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| DIARRHOEA | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| FEMORAL NECK FRACTURE | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| Nervous system disorders | ||||||||||
| CEREBRAL INFARCTION | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| Psychiatric disorders | ||||||||||
| DEPRESSION | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| LFX453 0.1% NMC | LFX453 0.15% LCC | Vehicle to NMC | Vehicle to LCC | Aldara | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/20 (50%) | 14/20 (70%) | 9/11 (81.8%) | 8/10 (80%) | 17/21 (81%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| HAEMOLYTIC ANAEMIA | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| INCREASED TENDENCY TO BRUISE | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| VERTIGO | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| VESTIBULAR DISORDER | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| Eye disorders | ||||||||||
| BLEPHARITIS | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| ABDOMINAL PAIN | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| ABDOMINAL PAIN UPPER | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| APHTHOUS ULCER | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| APICAL GRANULOMA | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| DIARRHOEA | 0/20 (0%) | 3/20 (15%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| GASTROOESOPHAGEAL REFLUX DISEASE | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| NAUSEA | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| TOOTHACHE | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| General disorders | ||||||||||
| APPLICATION SITE COLDNESS | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| APPLICATION SITE ERYTHEMA | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 5/21 (23.8%) | |||||
| APPLICATION SITE PRURITUS | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 2/21 (9.5%) | |||||
| APPLICATION SITE SCAB | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 2/21 (9.5%) | |||||
| CHILLS | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| FATIGUE | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 2/21 (9.5%) | |||||
| HYPOTHERMIA | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| INFLUENZA LIKE ILLNESS | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 3/21 (14.3%) | |||||
| NON-CARDIAC CHEST PAIN | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| Hepatobiliary disorders | ||||||||||
| CHOLELITHIASIS | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| Infections and infestations | ||||||||||
| BRONCHITIS | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| CYSTITIS | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| EYE INFECTION | 1/20 (5%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| GASTROENTERITIS | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| INFLUENZA | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| NASOPHARYNGITIS | 1/20 (5%) | 5/20 (25%) | 3/11 (27.3%) | 1/10 (10%) | 1/21 (4.8%) | |||||
| ORAL HERPES | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| PNEUMONIA | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| RELAPSING FEVER | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| SINUSITIS | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| TINEA PEDIS | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| CONTUSION | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| CORNEAL ABRASION | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| EYELID INJURY | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| HEAD INJURY | 0/20 (0%) | 1/20 (5%) | 1/11 (9.1%) | 1/10 (10%) | 1/21 (4.8%) | |||||
| LACERATION | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 1/10 (10%) | 0/21 (0%) | |||||
| MUSCLE RUPTURE | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| PERIORBITAL HAEMATOMA | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| RIB FRACTURE | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| Investigations | ||||||||||
| ANTIPSYCHOTIC DRUG LEVEL INCREASED | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| BLOOD CREATININE INCREASED | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| LYMPHOCYTE COUNT DECREASED | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| HYPOKALAEMIA | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| ARTHRALGIA | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| BACK PAIN | 0/20 (0%) | 1/20 (5%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| MUSCLE SPASMS | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| MYALGIA | 1/20 (5%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| MYOSCLEROSIS | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| NECK PAIN | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| OSTEOARTHRITIS | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| PAIN IN EXTREMITY | 1/20 (5%) | 1/20 (5%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| PERIARTHRITIS | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| BASAL CELL CARCINOMA | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| SEBORRHOEIC KERATOSIS | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| Nervous system disorders | ||||||||||
| AUTONOMIC NERVOUS SYSTEM IMBALANCE | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| BURNING SENSATION | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| DIZZINESS | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| HEADACHE | 0/20 (0%) | 0/20 (0%) | 2/11 (18.2%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| POLYNEUROPATHY | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| POOR QUALITY SLEEP | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| SCIATICA | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| Psychiatric disorders | ||||||||||
| AGITATION | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| BURNOUT SYNDROME | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| RENAL CYST | 0/20 (0%) | 0/20 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| COUGH | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| RHINITIS ALLERGIC | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| BLISTER | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| DRY SKIN | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| ECZEMA | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 0/21 (0%) | |||||
| ERYTHEMA | 1/20 (5%) | 0/20 (0%) | 0/11 (0%) | 0/10 (0%) | 1/21 (4.8%) | |||||
| PAIN OF SKIN | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
| SKIN EXFOLIATION | 0/20 (0%) | 0/20 (0%) | 0/11 (0%) | 1/10 (10%) | 1/21 (4.8%) | |||||
| Vascular disorders | ||||||||||
| HAEMATOMA | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 1/10 (10%) | 1/21 (4.8%) | |||||
| HYPERTENSION | 0/20 (0%) | 1/20 (5%) | 1/11 (9.1%) | 0/10 (0%) | 0/21 (0%) | |||||
| THROMBOSIS | 0/20 (0%) | 1/20 (5%) | 0/11 (0%) | 0/10 (0%) | 0/21 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02404389
Other Study ID Numbers:
- CLFX453X2201
First Posted:
Mar 31, 2015
Last Update Posted:
Jan 5, 2021
Last Verified:
Mar 1, 2019