Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses (NCT NCT02120898)

NCT ID: NCT02120898

Last Updated: 2019-12-13

Results Overview

Complete clearance rate (treatment success) was defined as the percentage of participants in each treatment group with a count of zero actinic keratosis (AK) lesions in the treatment area at Week 14. All AKs (baseline and new lesions) independent of size within the treatment area were included in the efficacy lesion count. The AK clearance rate for a participant was calculated as follows: {1 - \[ (number of AK lesions at Week 14) / (number of AK lesions at Baseline)\]} \* 100.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

467 participants

Primary outcome timeframe

Week 14

Results posted on

2019-12-13

Participant Flow

A total of 467 participants were enrolled and randomized in 2:2:1 to receive generic imiquimod cream 2.5%, zyclara® (imiquimod) cream 2.5%, or vehicle cream.

Participant milestones

Participant milestones
Measure	Generic Imiquimod Cream 2.5% Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Zyclara® (Imiquimod) Cream 2.5% Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Vehicle Cream Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
Overall Study STARTED	187	187	93
Overall Study Safety Population	187	187	93
Overall Study Intent-to-Treat (ITT) Population	183	185	93
Overall Study COMPLETED	178	181	89
Overall Study NOT COMPLETED	9	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Generic Imiquimod Cream 2.5% Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Zyclara® (Imiquimod) Cream 2.5% Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Vehicle Cream Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
Overall Study Withdrawal by Subject	4	2	2
Overall Study Non-compliance with study drug	3	0	0
Overall Study Adverse Event	1	2	1
Overall Study Protocol Violation	1	2	0
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Generic Imiquimod Cream 2.5% n=187 Participants Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Zyclara® (Imiquimod) Cream 2.5% n=187 Participants Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Vehicle Cream n=93 Participants Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Total n=467 Participants Total of all reporting groups
Age, Continuous	66.7 years STANDARD_DEVIATION 9.15 • n=5 Participants	66.1 years STANDARD_DEVIATION 9.82 • n=7 Participants	67.2 years STANDARD_DEVIATION 9.85 • n=5 Participants	66.7 years STANDARD_DEVIATION 9.6 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	23 Participants n=7 Participants	14 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	168 Participants n=5 Participants	164 Participants n=7 Participants	79 Participants n=5 Participants	411 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 14

Population: PP population, a subset of intent-to-treat (ITT) population (all randomized participants who applied at least 1 dose of study drug, and returned for at least 1 post-baseline evaluation) included participants who met all entry criteria, complaint with study drug and completed Week 14 evaluation with no protocol violation.

Outcome measures

Outcome measures
Measure	Generic Imiquimod Cream 2.5% n=161 Participants Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Zyclara® (Imiquimod) Cream 2.5% n=162 Participants Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Vehicle Cream n=83 Participants Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
Complete Clearance Rate - Percentage of Participants With Treatment Success: Per-Protocol (PP) Population	12.4 percentage of participants	13.6 percentage of participants	4.8 percentage of participants

PRIMARY outcome

Timeframe: Week 14

Population: ITT population included all randomized participants who applied at least 1 dose of study drug, and returned for at least 1 post-baseline evaluation.

Complete clearance rate (treatment success) was defined as the percentage of participants in each treatment group with a count of zero AK lesions in the treatment area at Week 14. All AKs (baseline and new lesions) independent of size within the treatment area were included in the efficacy lesion count. The AK clearance rate for a participant was calculated as follows: {1 - \[ (number of AK lesions at Week 14) / (number of AK lesions at Baseline)\]} \* 100.

Outcome measures

Outcome measures
Measure	Generic Imiquimod Cream 2.5% n=183 Participants Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Zyclara® (Imiquimod) Cream 2.5% n=185 Participants Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Vehicle Cream n=93 Participants Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
Complete Clearance Rate - Percentage of Participants With Treatment Success: ITT Population	12.6 percentage of participants	12.4 percentage of participants	4.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 14

Population: Safety population included all randomized participants who received study drug.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Mild AEs: awareness of sign or symptom, but easily tolerated. Moderate AEs: discomfort sufficient to cause interference with normal activities. Severe AEs: inability to carry out usual activities. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Outcome measures
Measure	Generic Imiquimod Cream 2.5% n=187 Participants Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Zyclara® (Imiquimod) Cream 2.5% n=187 Participants Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Vehicle Cream n=93 Participants Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
Number of Participants With Adverse Events (AEs) Any AEs	51 Participants	50 Participants	22 Participants
Number of Participants With Adverse Events (AEs) Any AEs in treatment area	7 Participants	5 Participants	5 Participants
Number of Participants With Adverse Events (AEs) SAEs in treatment area	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events (AEs) SAEs	6 Participants	4 Participants	2 Participants
Number of Participants With Adverse Events (AEs) Mild AEs	31 Participants	29 Participants	10 Participants
Number of Participants With Adverse Events (AEs) Moderate AEs	16 Participants	20 Participants	11 Participants
Number of Participants With Adverse Events (AEs) Severe AEs	4 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 14

Population: Safety population included all randomized participants who received study drug.

Local skin reactions included erythema, flaking/scaling/dryness, scabbing/crusting, pruritus, erosion/ulceration, pain, edema, and weeping/exudate. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Outcome measures
Measure	Generic Imiquimod Cream 2.5% n=187 Participants Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Zyclara® (Imiquimod) Cream 2.5% n=187 Participants Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Vehicle Cream n=93 Participants Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
Number of Participants With Local Skin Reactions Erythema	33 Participants	30 Participants	17 Participants
Number of Participants With Local Skin Reactions Flaking/Scaling/Dryness	32 Participants	29 Participants	22 Participants
Number of Participants With Local Skin Reactions Scabbing/Crusting	22 Participants	13 Participants	11 Participants
Number of Participants With Local Skin Reactions Pruritus	12 Participants	5 Participants	4 Participants
Number of Participants With Local Skin Reactions Erosion/Ulceration	3 Participants	2 Participants	1 Participants
Number of Participants With Local Skin Reactions Pain	2 Participants	2 Participants	0 Participants
Number of Participants With Local Skin Reactions Edema	2 Participants	2 Participants	0 Participants
Number of Participants With Local Skin Reactions Weeping/Exudate	1 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1) up to Week 6

Population: ITT population included all randomized participants who applied at least 1 dose of study drug, and returned for at least 1 post-baseline evaluation. Here 'Overall number of participants analyzed = participants evaluable for this outcome measure.

The overall drug compliance (%) = (Observed Consumption / Expected Consumption) \* 100%.

Outcome measures

Outcome measures
Measure	Generic Imiquimod Cream 2.5% n=182 Participants Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Zyclara® (Imiquimod) Cream 2.5% n=183 Participants Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Vehicle Cream n=93 Participants Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
Percentage of Drug Compliance	96.55 percentage of drug compliance Standard Deviation 10.233	97.83 percentage of drug compliance Standard Deviation 7.653	97.43 percentage of drug compliance Standard Deviation 9.410

Adverse Events

Generic Imiquimod Cream 2.5%

Serious events: 6 serious events

Other events: 16 other events

Deaths: 0 deaths

Zyclara® (Imiquimod) Cream 2.5%

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Generic Imiquimod Cream 2.5% n=187 participants at risk Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Zyclara® (Imiquimod) Cream 2.5% n=187 participants at risk Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Vehicle Cream n=93 participants at risk Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
Immune system disorders Autoimmune disorder	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Cardiac disorders Atrial fibrillation	1.1% 2/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Nervous system disorders Cerebrovascular accident	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Infections and infestations Pneumonia	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Gastrointestinal disorders Small intestinal obstruction	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	1.1% 1/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Vascular disorders Orthostatic hypotension	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	1.1% 1/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Vascular disorders Hypertensive crisis	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Psychiatric disorders Depression	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Cardiac disorders Coronary artery disease	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Nervous system disorders Presyncope	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.

Other adverse events

Other adverse events
Measure	Generic Imiquimod Cream 2.5% n=187 participants at risk Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Zyclara® (Imiquimod) Cream 2.5% n=187 participants at risk Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.	Vehicle Cream n=93 participants at risk Vehicle cream was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face \[excluding the ears\] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.
Gastrointestinal disorders Diarrhoea	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	2.1% 4/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
General disorders Application site pain	2.1% 4/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
General disorders Fatigue	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	2.1% 4/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Infections and infestations Nasopharyngitis	2.7% 5/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	2.2% 2/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Infections and infestations Sinusitis	1.6% 3/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.00% 0/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	2.2% 2/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Infections and infestations Upper respiratory tract infection	2.7% 5/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	2.7% 5/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	1.1% 1/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	0.53% 1/187 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.	2.2% 2/93 • Baseline (Day 1) up to Week 14 Safety population included all randomized participants who received study drug.

Additional Information

Director, CE Studies

Teva Pharmaceuticals Inc. USA

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
Publication restrictions are in place

Restriction type: OTHER