Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00948428
Other study ID # D94-3101-07
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 2008
Est. completion date April 2009

Study information

Verified date September 2020
Source Actavis Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream.


Description:

A nationwide, multicenter, double-blind, vehicle-controlled parallel group comparison study of a Generic Imiquimod cream, 5% (Actavis Mid-Atlantic LLC) and currently marketed Aldara (imiquimod) cream, 5% (distributed by Graceway Pharmaceuticals, LLC) was conducted in subjects with actinic keratoses (AKs) on the face and/or anterior scalp in order to evaluate the therapeutic equivalence of these two active treatments and to establish superiority of the efficacy of these two products over a Vehicle cream. Subjects were randomized to one of three treatment groups on a 2:2:1 basis as follows: (1) Generic Imiquimod cream, 5%, (2) Aldara (imiquimod) cream, 5%, and (3) Vehicle cream. The duration of treatment was 16 weeks (± 7 days).

The primary efficacy endpoint was the proportion of subjects in each treatment group with Complete Clearance (having no clinically visible actinic keratosis lesions in the 25 cm2 contiguous treatment area at the 8-week post-treatment visit) of AK lesions. The secondary efficacy endpoints were the Partial Clearance rates, defined as the proportion of subjects with at least a 75% reduction in the number of AK lesions counted at Baseline at the end-of-treatment visit (Week 16, EOT) and at the 8 weeks post-treatment visit/test-of-cure (Week 24, TOC), and the proportion of subjects with Complete Clearance of AK lesions at the end-of-treatment (Week 16, EOT) visit.

A 90% Wald's confidence interval with Yate's continuity correction was constructed around the difference between the proportions of subjects with Complete Clearance of AK lesions in the active treatments (Generic Imiquimod minus Aldara) to evaluate therapeutic equivalence in the primary efficacy analyses. Two-sided, continuity-corrected statistics were used to evaluate the superiority of each active treatment's Complete Clearance rate over that of the Vehicle treatment. The therapeutic comparability evaluations in the per-protocol (PP) population were considered primary while those in the intent-to-treat (ITT) population were considered supportive. The superiority comparisons in the ITT population were considered primary while those in the PP population were considered supportive. If the 90% confidence interval (CI) around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the PP population were contained within the interval 0.20 to +0.20, and each of these rates was greater than, and statistically different (p<0.05) from, the Vehicle rate in the ITT population, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.

Secondary efficacy analyses were conducted on the proportion of subjects in each treatment group with Complete Clearance of AK lesions at the Week 16, EOT visit as well as evaluation of the Partial Clearance of AK lesions at both the EOT and TOC visits. The results at both the EOT visit (Week 16) and those at 8 weeks post-treatment (Week 24, TOC) were statistically analyzed by the same methods described for the primary efficacy variable.

Both EOT and TOC analyses were conducted in the ITT population. The TOC analysis was conducted in the PP population and the EOT analysis was conducted in the EOT PP population.


Recruitment information / eligibility

Status Completed
Enrollment 462
Est. completion date April 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects were male or non-pregnant females, 18 years of age or older, in generally good health. Females who were post-menopausal, surgically sterile or using a medically acceptable form of birth control with a negative urine pregnancy test at the Baseline visit.

- Subjects provided written and verbal informed consent.

- Subjects presented to the clinic with at least 4 but no more than 12 visible, discrete nonhyperkeratotic, nonhypertrophic actinic keratosis lesions within a 25 cm2 Treatment Area on the face and/or anterior scalp.

- Subjects were willing and able to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

- Subjects who were lactating, or planning to become pregnant during the study.

- Subjects had hyperkeratotic, hypertrophic or large mat-like AKs within the 25 cm2 Treatment Area.

- Subjects who had the need or were planning to be exposed to artificial tanning devices or excessive sunlight during the trial.

- Subjects who were immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).

- Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.

- Subjects with known hypersensitivity or previous allergic reaction to any of the active or inactive components of the study drugs.

- Within 2 months: Facial and/or Anterior Scalp: laser resurfacing, photodynamic therapy, chemical peels, dermabrasion, topical application of 5-FU, imiquimod, diclofenac sodium or other treatments for AK or photodamage.

- Subjects who used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:

Within 2 days: Topicals of any kind to the selected Treatment Area. Within 2 weeks: Facial topical medications: corticosteroids, alpha- hydroxyacids (e.g., glycolic acid, lactic acid, etc. greater than 5%), beta-hydroxyacid (salicylic acid greater than 2%), urea - greater than 5% or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face and/or anterior scalp.

Within 2 weeks: Cryotherapy to lesions adjacent to or within the 25 cm2 Treatment Area.

Within 4 weeks: Systemic steroid therapy: chemotherapeutic agents, psoralens, immunotherapy, or retinoids.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
imiquimod
5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
Aldara™
5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
Vehicle Cream
Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

Locations

Country Name City State
United States DermResearch, Inc. Austin Texas
United States University Dermatology Consultants, Inc. Cincinnati Ohio
United States Cherry Creek Research, Inc. Denver Colorado
United States Deaconess Clinic, Inc. Evansville Indiana
United States Associates in Research, Inc. Fresno California
United States Minnesota Clinical Study Center Fridley Minnesota
United States Burke Pharmaceutical Research Hot Springs Arkansas
United States Suzanne Bruce & Associates, P.A. Houston Texas
United States Dermatology Associates of Knoxville, P.C. Knoxville Tennessee
United States FXM Research Corp. Miami Florida
United States Tennessee Clinical Research Center Nashville Tennessee
United States Mt. Sinai School of Medicine New York New York
United States MedaPhase, Inc. Newnan Georgia
United States Oregon Medical Research Center, P.C. Portland Oregon
United States Rhode Island Hospital, Dermatopharmacology Division Providence Rhode Island
United States Dermatology Research Center, Inc. Salt Lake City Utah
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States Skin Surgery Medical Group, Inc. San Diego California
United States Premier Clinical Research Spokane Washington
United States Derm Research Center of New York, Inc. Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Actavis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects in Each Treatment Group With Complete Clearance of AK Lesions at the Test of Cure Visit (Week 24) Week 24
Secondary Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to End of Treatment (EOT) Visit (Week 16). Week 16
Secondary Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to 8 Weeks Post Treatment (Test of Cure Visit). Week 24
See also
  Status Clinical Trial Phase
Completed NCT03575780 - Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis Phase 1
Completed NCT04085367 - Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face Phase 3
Completed NCT05937529 - Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis N/A
Completed NCT02520700 - A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses N/A
Terminated NCT01538901 - Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients Phase 4
Completed NCT01354717 - Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo Phase 3
Completed NCT00742391 - A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations Phase 3
Completed NCT03285477 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp Phase 3
Suspended NCT03963102 - Duration of Ameluz Application in Acral Actinic Keratoses Response Phase 4
Not yet recruiting NCT05923060 - Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses Phase 2
Withdrawn NCT06026358 - Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands Phase 4
Completed NCT02622594 - Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times Phase 4
Completed NCT00774787 - Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses Phase 4
Completed NCT00786994 - The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses Phase 2
Completed NCT00544258 - Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005 Phase 1
Completed NCT04024579 - Treatment of Actinic Keratosis With 5% KOH Solution
Completed NCT04843553 - Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients Early Phase 1
Completed NCT03315286 - Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure N/A
Completed NCT03279328 - Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents Phase 4
Completed NCT02062853 - Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video N/A