Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Generic imiquimod cream 2.5% will be 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 will apply test article for 14 consecutive days for each treatment cycle.

Zyclara® (imiquimod) cream 2.5% will be 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 will apply test article for 14 consecutive days for each treatment cycle.

Vehicle cream will be 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 will apply test article for 14 consecutive days for each treatment cycle.

Cream, generic formulation of the brand product.

Zyclara®

Vehicle cream in the same image of the generic imiquimod. Has no active ingredient.

Vehicle Cream

Study Director

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).

Aldara® (imiquimod) Cream, 5% was the first imiquimod product approved by the Food and Drug Administration (FDA) for the topical treatment of AK, superficial basal cell carcinoma and external genital and perianal warts. The FDA approved regimen for the treatment of AK is application of 250 milligrams (mg) of cream twice a week for 16 weeks to a 25 square centimeters (cm\^2) area. In 2011, a lower strength imiquimod cream, Zyclara (imiquimod) Cream, 2.5% was approved by the FDA. When used for the treatment of AK, Zyclara is applied for a shorter duration and in an expanded treatment area (for example, face or scalp) in comparison to Aldara®. This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP) and the applicable regulatory requirement(s). Marketed by Medicis, Zyclara® (imiquimod) cream 2.5% is a safe and effective topical therapy for the treatment of AK of the face and scalp. Actavis has developed a generic formulation of imiquimod 2.5% cream and the current study is designed to evaluate the safety and efficacy of this formulation.

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

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 2.5% and Zyclara® (Imiquimod) Cream, 2.5% in Subjects With Actinic Keratoses

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

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.

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.

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.

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.

Actavis Inc.

Safety population included all randomized participants who received study drug.

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.

Generic 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.

Zyclara® (Imiquimod) Cream 2.5%

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

Age, Continuous

Sex: Female, Male

Director, CE Studies

Analysis was performed using 90% Wald's confidence interval (CI) with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.

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.

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

Analysis was performed using 90% Wald's CI with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.

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 - Percentage of Participants With Treatment Success: ITT Population

Any AEs

Any AEs in treatment area

SAEs

SAEs in treatment area

Mild AEs

Moderate AEs

Severe AEs

Number of Participants With Adverse Events (AEs)

Erythema

Flaking/Scaling/Dryness

Scabbing/Crusting

Pruritus

Erosion/Ulceration

Pain

Edema

Weeping/Exudate

Number of Participants With Local Skin Reactions

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.

Percentage of Drug Compliance

Overall Study

Symptoms and General Pathology

Facies

Alopecia

Alopecia Areata

Zyclara® (imiquimod Cream), 3.75% (Medicis)

Imiquimod Cream, 3.75%

Vehicle of Test Product

To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the Vehicle cream.

Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis of the Face or Balding Scalp

The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses	NCT02120898	Actinic Keratos...	Imiquimod Zyclara® Vehicle Cream	18 Years -	Actavis Inc.
Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis	NCT01686152	Actinic Keratos...	Imiquimod Cream... Zyclara® Vehicle of Test...	18 Years -	Teva Pharmaceuticals USA
A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses	NCT02120898	Actinic Keratos...	Imiquimod Zyclara® Vehicle Cream	18 Years -	Actavis Inc.

Spots Global Cancer Trial Database for zyclara®

Every month we try and update this database with for zyclara® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for zyclara®

Every month we try and update this database with for zyclara® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for zyclara® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.