NCT02120898

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

Completed Phase 3 Results posted Last updated 13 December 2019

What this trial tests

Phase 3 trial testing Imiquimod in Actinic Keratosis in 467 participants. Completed in 30 April 2014.

Timeline

10 October 2013

Primary endpoint
30 April 2014

30 April 2014

Quick facts

Lead sponsor	Actavis Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	467
Start date	10 October 2013
Primary completion	30 April 2014
Estimated completion	30 April 2014
Sites	27 locations across United States

Drugs / interventions tested

• Imiquimod (IMIQUIMOD) — full drug profile →
• Zyclara® — full drug profile →
• Vehicle Cream — full drug profile →

Conditions studied

• Actinic Keratosis — all drugs for Actinic Keratosis →

Sponsor

Actavis Inc. — full company profile →

Who can join

18 and older, any sex, with Actinic Keratosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Complete Clearance Rate - Percentage of Participants With Treatment Success: Per-Protocol (PP) Population Primary · Week 14

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.

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	12.4
Zyclara® (Imiquimod) Cream 2.5%	13.6
Vehicle Cream	4.8

Complete Clearance Rate - Percentage of Participants With Treatment Success: ITT Population Primary · Week 14

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.

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	12.6
Zyclara® (Imiquimod) Cream 2.5%	12.4
Vehicle Cream	4.3

Number of Participants With Adverse Events (AEs) Secondary · Baseline (Day 1) up to Week 14

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

Any AEs

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	51
Zyclara® (Imiquimod) Cream 2.5%	50
Vehicle Cream	22

Any AEs in treatment area

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	7
Zyclara® (Imiquimod) Cream 2.5%	5
Vehicle Cream	5

SAEs

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	6
Zyclara® (Imiquimod) Cream 2.5%	4
Vehicle Cream	2

SAEs in treatment area

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	0
Zyclara® (Imiquimod) Cream 2.5%	0
Vehicle Cream	1

Mild AEs

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	31
Zyclara® (Imiquimod) Cream 2.5%	29
Vehicle Cream	10

Moderate AEs

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	16
Zyclara® (Imiquimod) Cream 2.5%	20
Vehicle Cream	11

Severe AEs

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	4
Zyclara® (Imiquimod) Cream 2.5%	1
Vehicle Cream	1

Number of Participants With Local Skin Reactions Secondary · Baseline (Day 1) up to Week 14

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.

Erythema

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	33
Zyclara® (Imiquimod) Cream 2.5%	30
Vehicle Cream	17

Flaking/Scaling/Dryness

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	32
Zyclara® (Imiquimod) Cream 2.5%	29
Vehicle Cream	22

Scabbing/Crusting

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	22
Zyclara® (Imiquimod) Cream 2.5%	13
Vehicle Cream	11

Pruritus

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	12
Zyclara® (Imiquimod) Cream 2.5%	5
Vehicle Cream	4

Erosion/Ulceration

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	3
Zyclara® (Imiquimod) Cream 2.5%	2
Vehicle Cream	1

Pain

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	2
Zyclara® (Imiquimod) Cream 2.5%	2
Vehicle Cream	0

Edema

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	2
Zyclara® (Imiquimod) Cream 2.5%	2
Vehicle Cream	0

Weeping/Exudate

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	1
Zyclara® (Imiquimod) Cream 2.5%	1
Vehicle Cream	0

Percentage of Drug Compliance Secondary · Baseline (Day 1) up to Week 6

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

Group	Value	95% CI
Generic Imiquimod Cream 2.5%	96.55	± 10.233
Zyclara® (Imiquimod) Cream 2.5%	97.83	± 7.653
Vehicle Cream	97.43	± 9.410

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline (Day 1) up to Week 14. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Generic Imiquimod Cream 2.5%

Serious: 6/187 (3%)

Deaths: —

Zyclara® (Imiquimod) Cream 2.5%

Serious: 4/187 (2%)

Deaths: —

Vehicle Cream

Serious: 2/93 (2%)

Deaths: —

Serious adverse events (12 terms)

Reaction	System	Generic Imiquimod Cream 2.5%	Zyclara® (Imiquimod) Cream…	Vehicle Cream
Atrial fibrillation	Cardiac disorders	—	—	—
Autoimmune disorder	Immune system disorders	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—
Hip fracture	Injury, poisoning and procedural complications	—	—	—
Orthostatic hypotension	Vascular disorders	—	—	—
Hypertensive crisis	Vascular disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—
Presyncope	Nervous system disorders	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Generic Imiquimod Cream 2.5%	Zyclara® (Imiquimod) Cream…	Vehicle Cream
Nasopharyngitis	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Application site pain	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Sinusitis	Infections and infestations	—	—	—
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Most-reported serious reactions: Atrial fibrillation, Autoimmune disorder, Cerebrovascular accident, Pneumonia, Osteoarthritis, Small intestinal obstruction, Hip fracture, Orthostatic hypotension.

Data from ClinicalTrials.gov NCT02120898 adverse events section.

Sponsor's own description

The purpose of this study it so compare the safety and efficacy profiles of a generic imiquimod 2.5% cream to the reference listed Zyclara® (imiquimod) cream in the treatment of actinic keratosis (AK).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pattern recognition receptors: function, regulation and therapeutic potential.
   Chen R, Zou J, Chen J, Zhong X, et al · · 2025 · cited 53× · PMID 40640149 · DOI 10.1038/s41392-025-02264-1