Actinic KeratosesPhase 3NCT01354717
Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo
A Phase 3 study testing Brand Carac and Generic 0.5% 5-fluorouracil cream in people with Actinic Keratoses, run by Spear Pharmaceuticals.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Brand Carac and Generic 0.5% 5-fluorouracil cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 377 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
Read the detailed description
actinic keratosis
- Conditions
- Actinic Keratoses
- Being tested
- Brand Carac, Generic 0.5% 5-fluorouracil cream, Placebo cream
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brand CaracDrug
Also called 5-fu
treatment of actinic keratosis
Generic 0.5% 5-fluorouracil creamDrug
Also called 5-fu
treatment of actinic keratosis
Placebo creamOther
treatment of actinic keratosis
| Study group | Role | What they receive |
|---|---|---|
| Brand Carac | Active comparator | Treatment of actinic keratosis with active ingredient Receives: Drug: Brand Carac |
| Generic 0.5% 5-fluorouracil cream | Active comparator | Treatment of actinic keratosis with active ingredient Receives: Drug: Generic 0.5% 5-fluorouracil cream |
| Placebo | Placebo comparator | treatment of actinic keratosis with placebo cream Receives: Other: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients with clearing
Measured: August 28, 2010 to March 17, 2011
Clearing of actinic keratosis
Measured: 42 days
Secondary outcomes (1)
superiority to placebo
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spear Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melanie Appell, M.D., Principal investigator, Alliance Clinical Research, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354717
- Sponsor's protocol ID
- Spear 0.5%
- Status last verified
- Oct 2014
- First submitted
- 14 May 2011
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Brand Generic and Placebo in Treatment of Actinic Keratosis
- ClinicalTrials.gov ID
- NCT01354717
- Acronym / sponsor ID
- Spear 0.5%
- Conditions
- Actinic Keratoses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Spear PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
actinic keratosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brand Carac | Active comparator | Drug: Brand CaracTreatment of actinic keratosis with active ingredient |
| Generic 0.5% 5-fluorouracil cream | Active comparator | Drug: Generic 0.5% 5-fluorouracil creamTreatment of actinic keratosis with active ingredient |
| Placebo | Placebo comparator | Other: Placebo creamtreatment of actinic keratosis with placebo cream |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- History of allergy or hypersensitivity to 5-fluorouracil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brand CaracAlso: 5-futreatment of actinic keratosis | Drug | Brand Carac |
| Generic 0.5% 5-fluorouracil creamAlso: 5-futreatment of actinic keratosis | Drug | Generic 0.5% 5-fluorouracil cream |
| Placebo creamtreatment of actinic keratosis | Other | Placebo |
Primary outcome
Percent of patients with clearing
Time frame: August 28, 2010 to March 17, 2011
Clearing of actinic keratosis
Time frame: 42 days
1 secondary outcome
superiority to placebo
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Appell, M.D. principal investigator
Alliance Clinical Research, Inc
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brand Carac and Generic 0.5% 5-fluorouracil cream in people with Actinic Keratoses, run by Spear Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients with clearing (time frame: August 28, 2010 to March 17, 2011). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.