Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Alopecia

Alopecia Areata

Skin Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.

imiquimod cream, 3.75%

Dosage form: Topical Cream Dosage: Placebo Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.

Vehicle Cream

Daniel Piacquadio, M.D.

Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week treatment cycles separated by a 2-week no treatment applied interval. A generic imiquimod cream, 3.75% has been developed by Actavis Mid-Atlantic LLC for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp.

The current clinical study is designed to evaluate the therapeutic equivalence of this formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation (Graceway Pharmaceuticals LLC).

A Bioequivalence Study With Clinical Endpoints Comparing Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses

Complete clearance rate (treatment success) was defined as the proportion of subjects in a treatment group with 100% clearance of all AK lesions within the Treatment Area. The primary efficacy endpoint was the proportion of subjects in the per-protocol (PP) population with treatment success at Week 14/EOS. All AKs (Baseline and new lesions), independent of size, within the Treatment Area were included in the AK lesion counts.

Measures of test article compliance included the total number of days of test article applications recorded on the CRFs and verified from the data in the subject diaries. Compliant subjects were defined as those who applied at least 75% and no more than 125% of the test article applications.

The severity and frequency of adverse events (AEs) were assessed in the three treatment groups.

The severity and frequency of local skin reactions (LSRs) were assessed in the three treatment groups.

Partial clearance rate was defined as the proportion of subjects in a treatment group with 75% or more reduction in the AK count in the Treatment Area at Week 14/EOS as compared to Baseline.

Percent change in the AK number as compared to Baseline at Week 14/EOS was a secondary outcome.

Actavis Mid-Atlantic LLC

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Bioequivalence Study With Clinical Endpoints Comparing Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses	NCT01502020	Actinic Keratos...	imiquimod cream... Vehicle Cream imiquimod cream...	18 Years -	Actavis Mid-Atlantic LLC
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.
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.