- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01354717
Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo
October 9, 2014 updated by: Spear Pharmaceuticals
Phase 3 Study of Brand Generic and Placebo in Treatment of Actinic Keratosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
actinic keratosis
Study Type
Interventional
Enrollment (Actual)
377
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Brand Carac
Treatment of actinic keratosis with active ingredient
|
treatment of actinic keratosis
Other Names:
|
Active Comparator: Generic 0.5% 5-fluorouracil cream
Treatment of actinic keratosis with active ingredient
|
treatment of actinic keratosis
Other Names:
|
Placebo Comparator: Placebo
treatment of actinic keratosis with placebo cream
|
treatment of actinic keratosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent of patients with clearing
Time Frame: August 28, 2010 to March 17, 2011
|
August 28, 2010 to March 17, 2011
|
Clearing of actinic keratosis
Time Frame: 42 days
|
42 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
superiority to placebo
Time Frame: 42 days
|
42 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Irritation
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Melanie Appell, M.D., Alliance Clinical Research, Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
May 14, 2011
First Submitted That Met QC Criteria
May 14, 2011
First Posted (Estimate)
May 17, 2011
Study Record Updates
Last Update Posted (Estimate)
October 20, 2014
Last Update Submitted That Met QC Criteria
October 9, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Spear 0.5%
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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