Clinical trial NCT01502020: A Bioequivalence Study With Clinical Endpoints Comparing Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Actinic Keratoses
Keywords: actinic keratoses
actinic keratosis
imiquimod, 3.75%
imiquimod
Zyclara
Actinic keratoses of the face or balding scalp
Lead sponsor: Actavis Mid-Atlantic LLC
Sponsor class: INDUSTRY
First posted: 2011-12-30
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Subject was male or female, 18 years of age or older.
* Subject provided written informed consent.
* Subject was willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
* Subject had a clinical diagnosis of actinic keratoses (AK) with at least five (5) and no more than 20 clinically typical, visible or palpable AK lesions, each at least 4mm in diameter, in an area greater than 25cm2 on the face (excluding ears) or balding scalp, but not both.
* Subject was in good general health and free of any disease state or physical condition that might have impaired evaluation of AK lesions or which, in the investigator's opinion, exposed the subject to an unacceptable risk by study participation.
* If subject was a woman of childbearing potential (WOCBP), she must have had a negative urine pregnancy test (UPT) and agreed to use an effective form of birth control for the duration of the study (e.g., abstinence, stabilized on hormonal contraceptives for at least three months \[oral, implant, injection, IUD, patch or NuvaRing\] condom and spermicidal or diaphragm and spermicidal). Abstinence was an acceptable form of birth control for subjects who were not sexually active. Subjects who became sexually active during the trial had to agree to use an effective, non-prohibited form of birth control for the duration of the study.

Exclusion Criteria:

* Subject was pregnant, lactating, or planning to become pregnant during the study.
* Subjects had hyperkeratotic, hypertrophic or atypical AKs (e.g., AK \> 1 cm2 in size) in the Treatment Area.
* Subject was enrolled in an investigational drug or device study during the study period.
* Subject was planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
* Subject was immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
* Subject had experienced an unsuccessful outcome from previous imiquimod therapy (An unsuccessful outcome was defined as after a reasonable therapeutic trial with no compliance issues, topical application did not work).
* Subject had used an investigational drug or investigational device within 30 days prior to the Baseline Visit.
* Subject had laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, UVB therapy, chemical peels or dermabrasion on the face or balding scalp within 6 months prior to the Baseline Visit.
* Subject had cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision or other treatments for actinic keratosis on the face or scalp within one month prior to the Baseline Visit.
* Subject had used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies or retinoids within one month prior to the Baseline Visit.
* Subject had used topical medications, corticosteroids, alpha hydroxy acids (e.g., glycolic acid, lactic acid etc. \> 5%), beta hydroxy acid (salicylic acid \> 2%), urea \>5%, 5-fluorouracil, diclofenac, imiquimod or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face or balding scalp within one month prior to the Baseline Visit.
* Subject had used topical creams, lotions or gels of any kind to the selected Treatment Area within one day prior to the Baseline Visit.
* Subject had a basal cell or squamous cell carcinoma within the Treatment Area within one year of study enrollment.
* Subject had a history of sensitivity to any of the ingredients in the test articles.
* Subject had any skin pathology or condition (e.g., facial/scalp psoriasis, atopic dermatitis, acne, rosacea, etc.) that, in the investigator's opinion, could have interfered with the evaluation of the test article, worsened due to the treatment or required the use of interfering topical, systemic or surgical therapy.
* Subject had any condition which, in the investigator's opinion, would have made it unsafe or precluded the subject's ability to fully participate in the research study.
* Subject was known to be noncompliant or was unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Primary outcomes:
measure: Complete clearance rate
timeFrame: 8 weeks post treatment period
measure: Dosing Compliance
timeFrame: 8 weeks post treatment period
measure: Adverse Events
timeFrame: 14 weeks
measure: Local Skin Reactions
timeFrame: 14 weeks
Secondary outcomes:
measure: Partial Clearance Rate
timeFrame: 8 weeks post treatment
measure: Percent Change in the AK number
timeFrame: 8 weeks post treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trials Center
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Clinton Township
country: United States
facility: Michigan Center for Research Corp.
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, P.C.
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas,
state: North Carolina
city: Cincinnati
country: United States
facility: Dermatology Research Center of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Fort Washington
country: United States
facility: Philadelphia Institute of Dermatology
state: Pennsylvania
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A.
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
Study officials:
affiliation: Therapeutics, Inc.
name: Daniel Piacquadio, M.D.
role: STUDY_DIRECTOR
References: