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A Randomized, Double Blind, Placebo Controlled, Parallel Design, Multiple Site, Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis

Thank you

Trial Information

A Randomized, Double Blind, Placebo Controlled, Parallel Design, Multiple Site, Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis.


Inclusion Criteria:



- Signed informed consent form.

- Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.

- Diagnosis of actinic keratosis with at least 5 and no more than 20 clinically
typical, visible or palpable actinic keratosis lesions, each at least 4 mm in
diameter, in an area that exceeds 25 cm2 on either the face (excluding ear) or
balding scalp (but not both.)

- Women either must be 1 year post-menopausal, surgically sterile, or if they are of
child-bearing potential, they must: a) have been using systemic birth control,
intrauterine device, or Norplant for at least 28 days prior to the start of treatment
period, or used barrier methods consistently, at least 14 days before study cream
administration; b) had a normal menstrual cycle for the month prior to the start of
treatment; c) have a negative urine pregnancy test result upon entry into the study;
d) agree to use a medically accepted form of birth control throughout the study
period.

- Free from any systemic or dermatologic disorder that, in the opinion of the
Investigator, will interfere with the study results or increase the risk of adverse
events.

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

- Willingness and capability to cooperate to the extent and degree required by the
protocol.

Exclusion Criteria:

- Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema,
psoriasis, rosacea, sunburn or other possible confounding skin conditions on the face
or bald scalp.

- Use within six months prior to baseline on the face or bald scalp of chemical peel,
dermabrasion, laser abrasion, psoralen plus ultraviolet A therapy, or ultra violet B
therapy.

- Use within one month prior to baseline on the face or bald scalp of cryodestruction
or chemodestruction, curettage, photodynamic therapy, surgical excision, topical
5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod,
topical retinoids or other treatments for actinic keratosis including glycolic acids
or over-the-counter products containing retinol, alpha or beta hydroxy acids.

- Use within one month prior to baseline of immunomodulators or immunosuppressive
therapies, interferon, oral corticosteroids or cytotoxic drugs.

- Known allergies to imiquimod or any excipients to the test or reference creams.

- Receiving 5-fluorouracil or other systemic cancer chemotherapy within 6 months prior
to study entry.

- Any condition, medical, psychological, or social, that, in the Investigator's
opinion, would interfere with participation in the study.

- Women who are pregnant or planning pregnancy or lactating during the study.

- Participation in any investigational drug study within 30 days of enrollment or
previous participation in this study.

- Employees or family members of employees of the research center or Investigator.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Treatment success

Outcome Description:

Treatment success will be defined by the proportion of patients in the per protocol population with 100% clearance of all actinic keratosis lesions within the treatment area at study week 14 (8 weeks after completion of treatment.)

Outcome Time Frame:

Week 14 (8 weeks after completion of treatment)

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

IMQC 1220

NCT ID:

NCT01788007

Start Date:

January 2013

Completion Date:

November 2013

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • Imiquimod Topical Cream 3.75%
  • Zyclara┬« (imiquimod) Topical Cream 3.75%
  • Keratosis
  • Keratosis, Actinic

Name

Location

Fountain Valley, California  92708
Miami, Florida  33176
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Omaha, Nebraska  68114
Denver, Colorado  
Charlotte, North Carolina  
Eugene, Oregon  
Indianapolis, Indiana  
Sioux Falls, South Dakota