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A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis


Phase 3
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis

Thank you

Trial Information

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis


Inclusion Criteria:



- Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic
AK lesions within a 25 cm2 contiguous treatment area on either the face or balding
scalp

- Women either must be 1 year post-menopausal, surgically sterile, or agree to use a
medically accepted form or birth control

- Free of any systemic or dermatological disorder

- Any skin type or race, providing the skin pigmentation will allow discernment of
erythema

Exclusion Criteria:

- Basal cell or squamous cell carcinoma, or other possible confounding skin conditions
(on face and scalp)

- History of cutaneous hyperreactivity or facial irritation to topical products

- Engaging in activities involving excessive or prolonged exposure to sunlight

- Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser
abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study
entry

- Currently using or have used systemic steroids 2 months prior to study

- Currently using or have used on the treatment area over-the-counter retinol products,
corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic
keratosis treatments 28 days prior to randomization

- Pregnant or nursing mothers

- History of allergy or sensitivity to imiquimod or related compounds or other
components of the formulation

- Taking immunosuppressant medication

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Darin B Brimhall, D.O.

Investigator Role:

Study Director

Investigator Affiliation:

Novum Pharmaceutical Research Services

Authority:

United States: Institutional Review Board

Study ID:

MIQ-0403

NCT ID:

NCT00828568

Start Date:

June 2008

Completion Date:

May 2009

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma

Name

Location

Welborn ClinicEvansville, Indiana  47714
Piedmont Medical Research AssociatesWinston Salem, North Carolina  27103
Dermatology Associates of TylerTyler, Texas  75703
J & S Studies, Inc.College Station, Texas  77845
Horizon Clinical Research Associates, PLLCGilbert, Arizona  
Premiere Pharmaceutical Research, LLCTempe, Arizona  
Genova Clinical Research, IncTuscon, Arizona  
Horizons Clinical Research Center, LLCDenver, Colorado  
North Florida Dermatology AssociatesJacksonville, Florida  
FXM Research Corp.Miami, Florida  
International Dermatology Research, Inc.Miami, Florida  
Indiana Clinical Trial CenterPlainfield, Indiana  
Compliant Clinical Research, Inc.Olathe, Kansas  
Compliant Clinical Research of Wichita, IncWichita, Kansas  
Skin Specialists, PCOmaha, Nebraska  
K. Heine Clinical TrialsHenderson, Nevada  
Cary Dermatology CenterCary, North Carolina  
Unifour Medical Research AssociatesHickory, North Carolina  
Dermatology Consulting ServicesHigh Point, North Carolina  
Palmetto Clinical Trial Services, LLCSimpsonville, South Carolina  
Murfreesboro DermatologyMurfreesboro, Tennessee