Multiple Actinic KeratosesPhase 3NCT06851507
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
A Phase 3 study testing Fluorouracil 5-FU and Fluorouracil/Calcipotriene in people with Multiple Actinic Keratoses, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to compare the effects of topical fluorouracil alone to topical fluorouracil plus topical calcipotriene in patients with multiple actinic keratoses. "Topical" means the medication is applied directly to the skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Actinic Keratoses
- What is being tested?
- Fluorouracil 5-FU and Fluorouracil/Calcipotriene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2025to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to start treatment within 1 week of enrollment
- Patients must be age ≥18, not of childbearing potential, and have the presence of 4-15 clinically, visibly confirmed and discrete AKs in an at least 25 cm2 contiguous area on the head, neck, arm, or hand.
- Because no dosing or adverse event data are currently available on the use of fluorouracil in combination with calcipotriene in patients <18 years of age, children are excluded from this study.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- The effects of topical fluorouracil and/or fluorouracil plus calcipotriene on the developing human fetus are unknown. From the topical fluorouracil package insert: "One birth defect (cleft lip and palate) has been reported in the newborn of a patient using EFUDEX as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when EFUDEX was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil."11 For this reason, we are excluding women of child-bearing potential. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Known allergy to any component of the medications or vehicle.
- A wound or suspected skin cancer within 5cm of the area to be treated
- Immunosuppression, or use in the past month of medications that could impede skin assessment including but not limited to:
- Other topical medications with active ingredients including: topical steroids, topical calcineurin inhibitors, topical retinoids, imiquimod, diclofenac, etc.
- Artificial tanners Cytotoxic medications including: systemic fluorouracil, bleomycin, doxorubicin, cisplatin, etc.
- Ultraviolet therapy Oral nicotinamide Oral retinoids including: isotretinoin, acitretin
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- History of hypercalcemia
- Clinical evidence of vitamin D toxicity
- The effects of topical fluorouracil and/or fluorouracil plus calcipotriene on the developing human fetus are unknown. From the topical fluorouracil package insert: "One birth defect (cleft lip and palate) has been reported in the newborn of a patient using EFUDEX as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when EFUDEX was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil."11 For this reason, we are excluding women of child-bearing potential. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to compare the effects of topical fluorouracil alone to topical fluorouracil plus topical calcipotriene in patients with multiple actinic keratoses. "Topical" means the medication is applied directly to the skin.
Read the detailed description
Primary Objectives:
The primary objective of this pilot trial is feasibility, specifically measured by percent of patients approached and screened who enroll in the study. The prior trial on these medications reported a 75% enrollment rate (132 enrolled of 175 patients screened), though other trials of AK treatments have had lower enrollment rates (e.g., 53%9). To accurately plan a multi-site trial and apply for funding, an enrollment rate from the pilot trial will be critical. We will consider 50% enrollment rate a success, based on the lowest enrollment rates we found in the AK trial literature.
Secondary Objectives:
- The proportion of participants who complete the treatment course, B. The change in AK count from baseline C. The proportion of participants who have clearance of >75% of AKs D. Differences in adverse event reporting, in particular redness, scaling, burning, pain, and itch, E. Comparison of counts of AK lesions by dermatologists in person to counts of AK lesions by dermatologists using standardized digital photography.
- Change in MASCK metric G. Patient satisfaction (AK-EPQ) H. Change in health related QoL (AK-QoL) I. Patient adherence (ability to complete entire recommended course)
- Conditions
- Multiple Actinic Keratoses
- Being tested
- Fluorouracil 5-FU, Fluorouracil/Calcipotriene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorouracil 5-FUDrug
Participants in the fluorouracil arm will apply fluorouracil twice daily for 2-3 weeks (depending on body area).
Fluorouracil/CalcipotrieneDrug
Participants in the fluorouracil/calcipotriene will apply fluorouracil/calcipotriene twice daily for 4 days to the affected area.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Fluorouracil and Calcipotriene | Experimental | Participants will screened and enrolled during a standard-of-care clinical dermatology visit. Participants will be randomized in between treatment with topical 5-FU twice daily for 2-3 weeks Receives: Drug: Fluorouracil/Calcipotriene |
| Treatment with Fluorouracil | Experimental | Participants will screened and enrolled during a standard-of-care clinical dermatology visit. Participants will be randomized in between treatment with topical 5-FU twice daily for 2-3 weeks Receives: Drug: Fluorouracil 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start6 Oct 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Actinic KeratosesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mackenzie Wehner, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851507
- Sponsor's protocol ID
- 2024-2003
- Other IDs
- NCI-2025-01497
- Status last verified
- Nov 2026
- First submitted
- 24 Feb 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
- ClinicalTrials.gov ID
- NCT06851507
- Acronym / sponsor ID
- 2024-2003
- Conditions
- Multiple Actinic Keratoses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Feb 2025 (actual)
- 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.
The goal of this clinical research study is to compare the effects of topical fluorouracil alone to topical fluorouracil plus topical calcipotriene in patients with multiple actinic keratoses. "Topical" means the medication is applied directly to the skin.
Detailed description
Primary Objectives:
The primary objective of this pilot trial is feasibility, specifically measured by percent of patients approached and screened who enroll in the study. The prior trial on these medications reported a 75% enrollment rate (132 enrolled of 175 patients screened), though other trials of AK treatments have had lower enrollment rates (e.g., 53%9). To accurately plan a multi-site trial and apply for funding, an enrollment rate from the pilot trial will be critical. We will consider 50% enrollment rate a success, based on the lowest enrollment rates we found in the AK trial literature.
Secondary Objectives:
- The proportion of participants who complete the treatment course, B. The change in AK count from baseline C. The proportion of participants who have clearance of >75% of AKs D. Differences in adverse event reporting, in particular redness, scaling, burning, pain, and itch, E. Comparison of counts of AK lesions by dermatologists in person to counts of AK lesions by dermatologists using standardized digital photography.
- Change in MASCK metric G. Patient satisfaction (AK-EPQ) H. Change in health related QoL (AK-QoL) I. Patient adherence (ability to complete entire recommended course)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Fluorouracil and Calcipotriene | Experimental | Drug: Fluorouracil/CalcipotrieneParticipants will screened and enrolled during a standard-of-care clinical dermatology visit. Participants will be randomized in between treatment with topical 5-FU twice daily for 2-3 weeks |
| Treatment with Fluorouracil | Experimental | Drug: Fluorouracil 5-FUParticipants will screened and enrolled during a standard-of-care clinical dermatology visit. Participants will be randomized in between treatment with topical 5-FU twice daily for 2-3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to start treatment within 1 week of enrollment
- Patients must be age ≥18, not of childbearing potential, and have the presence of 4-15 clinically, visibly confirmed and discrete AKs in an at least 25 cm2 contiguous area on the head, neck, arm, or hand.
- Because no dosing or adverse event data are currently available on the use of fluorouracil in combination with calcipotriene in patients <18 years of age, children are excluded from this study.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- The effects of topical fluorouracil and/or fluorouracil plus calcipotriene on the developing human fetus are unknown. From the topical fluorouracil package insert: "One birth defect (cleft lip and palate) has been reported in the newborn of a patient using EFUDEX as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when EFUDEX was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil."11 For this reason, we are excluding women of child-bearing potential. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Key exclusion criteria (11 listed)
- Known allergy to any component of the medications or vehicle.
- A wound or suspected skin cancer within 5cm of the area to be treated
- Immunosuppression, or use in the past month of medications that could impede skin assessment including but not limited to:
- Other topical medications with active ingredients including: topical steroids, topical calcineurin inhibitors, topical retinoids, imiquimod, diclofenac, etc.
- Artificial tanners Cytotoxic medications including: systemic fluorouracil, bleomycin, doxorubicin, cisplatin, etc.
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 |
|---|---|---|
| Fluorouracil 5-FUParticipants in the fluorouracil arm will apply fluorouracil twice daily for 2-3 weeks (depending on body area). | Drug | Treatment with Fluorouracil |
| Fluorouracil/CalcipotrieneParticipants in the fluorouracil/calcipotriene will apply fluorouracil/calcipotriene twice daily for 4 days to the affected area. | Drug | Treatment with Fluorouracil and Calcipotriene |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Mackenzie Wehner, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluorouracil 5-FU and Fluorouracil/Calcipotriene in people with Multiple Actinic Keratoses, run by M.D. Anderson Cancer Center at 1 site in United States.
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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year.). 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 3 Nov 2026.