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Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo

This study has been completed.
Information provided by (Responsible Party):
Spear Pharmaceuticals Identifier:
First received: May 14, 2011
Last updated: October 9, 2014
Last verified: October 2014
This is a double-blind, randomized, placebo-controlled, three treatment parallel study in which normal, healthy men and women (age 45-85) with actinic keratosis will be treated on the face once daily for two weeks with 5-Fluorouracil Cream 0.5%, Spear Pharmaceuticals (Generic), Carac® Cream 0.5% (Brand), or Cream Vehicle (Placebo). Actinic keratoses will be counted at the baseline visit and at the visit four weeks following cessation of treatment.

Condition Intervention Phase
Actinic Keratoses Drug: Brand Carac Drug: Generic 0.5% 5-fluorouracil cream Other: Placebo cream Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Brand Generic and Placebo in Treatment of Actinic Keratosis

Resource links provided by NLM:

Further study details as provided by Spear Pharmaceuticals:

Primary Outcome Measures:
  • Percent of patients with clearing [ Time Frame: August 28, 2010 to March 17, 2011 ]
  • Clearing of actinic keratosis [ Time Frame: 42 days ]

Secondary Outcome Measures:
  • superiority to placebo [ Time Frame: 42 days ]

Other Outcome Measures:
  • Irritation [ Time Frame: 14 days ]

Enrollment: 377
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brand Carac
Treatment of actinic keratosis with active ingredient
Drug: Brand Carac
treatment of actinic keratosis
Other Name: 5-fu
Active Comparator: Generic 0.5% 5-fluorouracil cream
Treatment of actinic keratosis with active ingredient
Drug: Generic 0.5% 5-fluorouracil cream
treatment of actinic keratosis
Other Name: 5-fu
Placebo Comparator: Placebo
treatment of actinic keratosis with placebo cream
Other: Placebo cream
treatment of actinic keratosis

Detailed Description:
actinic keratosis

Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Men and women with the presence of actinic keratoses

  • 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 study
  • Have provided written informed consent

Exclusion Criteria:

  • History of allergy or hypersensitivity to 5-fluorouracil

    • Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01354717

Sponsors and Collaborators
Spear Pharmaceuticals
Principal Investigator: Melanie Appell, M.D. Alliance Clinical Research, Inc
  More Information

Responsible Party: Spear Pharmaceuticals Identifier: NCT01354717     History of Changes
Other Study ID Numbers: Spear 0.5%
Study First Received: May 14, 2011
Last Updated: October 9, 2014

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on June 22, 2017