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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


N/A
18 Years
N/A
Not Enrolling
Both
Actinic Keratoses

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Complete clearance rate

Outcome Description:

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.

Outcome Time Frame:

8 weeks post treatment period

Safety Issue:

No

Principal Investigator

Daniel Piacquadio, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Therapeutics, Inc.

Authority:

United States: Institutional Review Board

Study ID:

094-3152-301

NCT ID:

NCT01502020

Start Date:

February 2011

Completion Date:

November 2011

Related Keywords:

  • Actinic Keratoses
  • actinic keratoses
  • actinic keratosis
  • imiquimod, 3.75%
  • imiquimod
  • Zyclara
  • Actinic keratoses of the face or balding scalp
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma

Name

Location

Minnesota Clinical Study CenterFridley, Minnesota  55432
Academic Dermatology AssociatesAlbuquerque, New Mexico  87106
Dermatology Clinical Research Center of San AntonioSan Antonio, Texas  78229
DermResearch, Inc.Austin, Texas  78759
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Philadelphia Institute of DermatologyFort Washington, Pennsylvania  19034
Dermatology SpecialistsLouisville, Kentucky  40202
Northwest Clinical TrialsBoise, Idaho  83704
Deaconess Clinic, Inc.Evansville, Indiana  47713
International Dermatology Research, Inc.Miami, Florida  
MedaPhase, Inc.Newman, Georgia  30263
Oregon Medical Research Center, PCPortland, Oregon  97223
Dermatology Research Center of CincinnatiCincinnati, Ohio  45220
Total Skin and Beauty Dermatology Center, PCBirmingham, Alabama  35205
Indiana Clinical Trials CenterPlainfield, Indiana  46168
Michigan Center for Research Corp.Clinton Township, Michigan  48038
Skin Specialists, P.C.Omaha, Nebraska  68144
Dermatology, Laser & Vein Specialists of the Carolinas,Charlotte, North Carolina  28207
Suzanne Bruce and Associates, P.A.Houston, Texas  77056