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Phase 3 Study of Brand Generic and Placebo in Treatment of Actinic Keratosis

Phase 3
45 Years
85 Years
Not Enrolling
Actinic Keratoses

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Trial Information

Phase 3 Study of Brand Generic and Placebo in Treatment of Actinic Keratosis

Inclusion Criteria:

Men and women with the presence of actinic keratosis

- Age 45-85 years, inclusive

- Women who have had surgical sterilization or are post-menopausal (absence of menses
for at least one year) are eligible. Women of child-bearing potential who are
non-pregnant and non-nursing, and willing to avoid pregnancy during the course of the
study and during the menstrual cycle following completion of their participation in
the study are eligible. (Adequate contraception is defined as regular use of,
diaphragm with condoms, IUD with condoms, or systemic contraceptives - if used for at
least three months prior to enrollment in the study). A negative pregnancy test is
required at entry into the study

- Able to refrain from the use of all other topical medications to the facial area
during the treatment period

- Considered reliable and capable of understanding their responsibility and role in the

- Have provided written informed consent

Exclusion Criteria:

- History of allergy or hypersensitivity to 5-fluorouracil

- Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency

- More than 10 lesions total on the face (Lesions that are hyperkeratotic, thicker
than 1 mm (a piece of paper) or larger than 9 mm, or lesions suspicious for
squamous cell carcinoma will not be included in lesion counts.)

- Clinical evidence of severe, uncontrolled auto-immune, cardiovascular,
gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or
renal disease

- Dermatologic conditions if present on the face such as: atopic dermatitis, basal
cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, or albinism

- Positive urine pregnancy test in women of child-bearing potential

- Inability to use adequate birth control measures for women of child-bearing
potential, as defined above

- Serious psychological illness

- Significant history (within the past year) of alcohol or drug abuse

- Participation in any clinical research study during the 30 day period preceding
study initiation

- Medical history which, based on the clinical judgment of the investigator,
implies an unlikelihood of successful completion of the study

- Treatment for actinic keratosis or skin cancer in the previous 28 days with the
following: topical 5 fluorouracil, cryodestruction (liquid nitrogen spray),
curettage (scraping of pre-cancer or skin cancers), surgical removal of skin
cancer, photodynamic therapy, surgical excision, topical diclofenac (Solaraze),
topical imiquimod (Aldara), topical retinoids if used for actinic keratosis or
other treatments for actinic keratoses

- Application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA
(psoralen plus ultraviolet A) therapy, or 5) UVB therapy to the face or bald
scalp within six months prior to randomization

- Use of sun lamps or sun tanning beds or booths during the 2 weeks prior to first
application until Day 42 visit

- Any oral (systemic steroids) or topical corticosteroids within 1 month of study
entry, except for subjects on chronic low dose corticosteroids less than 5 mg
daily for greater than 1 year

- Use within 1 month of any immunomodulators like interferon, or cytotoxic drugs

- Prior treatment with systemic 5-fluorouracil or systemic cancer therapy within 6
months of study entry

- Subjects with lesions suspicious for squamous cell carcinoma

Type of Study:


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:

Percent of patients with 100% clearing

Outcome Time Frame:

6 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

March 2011

Related Keywords:

  • Actinic Keratoses
  • Keratosis
  • Keratosis, Actinic