Superficial Basal Cell CarcinomaPhase 2/3NCT05381597
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
A Phase 2/3 study testing Combination cream of 5-fluorouracil and calcipotriene and 5-fluorouracil cream in people with Superficial Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ, run by Boston University at 1 site in United States.
Trial summary
The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Basal Cell Carcinoma, Squamous Cell Carcinoma in Situ
- What is being tested?
- Combination cream of 5-fluorouracil and calcipotriene and 5-fluorouracil cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to Jun 2027
- Phase
- Phase 2/3
- 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
- English-speaking
- Having a previously untreated, biopsy-proven Superficial Basal Cell Carcinoma (sBCC) or Squamous Cell Carcinoma in Situ (SCCis) of the skin <2 cm on the scalp, trunk, neck, or extremities, excluding hands, feet, and genitalia
- Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical candidates
- Willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits
- Participants may have multiple lesions enrolled in the study so long as the individual lesions are greater than 2 cm from each other
- If a woman is of childbearing potential, the participant must be willing to take a pregnancy test before starting treatment and be on some form of birth control while receiving treatment. Birth control can include abstinence, oral contraceptive pill, intrauterine device, implanted birth control device, birth control patch, or the vaginal ring. The patient does not need to be on any form of birth control after they end therapy.
Who cannot join
- Current or prior field treatment within 2 cm of the target BCC or SCCis
- Periorbital lesions
- Lesions that have been previously treated
- Known allergy to any of the study medication ingredients
- History of solid organ transplant or current immunosuppression
- Genetic disorders associated with high skin cancer risk
Show all 15Show fewer
- Arsenic exposure
- Cutaneous T-cell lymphoma
- Current or prior radiation therapy at the site of the sBCC or SCCis
- Women who are pregnant or currently breastfeeding
- Prior psoralen plus Ultraviolet light (UVA) treatment at the site
- Very high mortality risk at the start of the study
- Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
- Demonstrated hypercalcemia or evidence of vitamin D toxicity
- Lesions that extend into the oral, nasal or genital mucosa
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center Dermatology Clinic
Boston, Massachusetts, 02118
Bilal Fawaz, MD, 617-358-9700, bilal.fawaz@bmc.org
Frederick Gibson, MD, (617) 358-9700, frederick.gibson@bmc.org
About this study
Official title: Combination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ
The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers.
The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with
The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place.
- Being tested
- Combination cream of 5-fluorouracil and calcipotriene, 5-fluorouracil cream
- Keywords
- 5-fluorouracil cream, fluorouracil with calcipotriene
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination cream of 5-fluorouracil and calcipotrieneDrug
Also called compounded cream
Apply the cream to the size of the lesion extending to the 0.5 cm area of skin surrounding the lesion.twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.
5-fluorouracil creamDrug
Also called usual treatment
Apply the cream to the size of their lesion extending to the 0.5 cm area of skin surrounding the lesion twice daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Combination cream of 5-fluorouracil and calcipotriene | Experimental | Participants randomized to this group will receive treatment with the combination cream consisting of 5-fluorouracil and calcipotriene twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days. Receives: Drug: Combination cream of 5-fluorouracil and calcipotriene |
| 5-fluorouracil cream | Active comparator | Participants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days. Receives: Drug: 5-fluorouracil cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance rate of cancer lesions at 3 months
Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
Measured: 3 months
Clearance rate of cancer lesions at 3 years
Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
Measured: 3 years
Secondary outcomes (12)
Percent of participants that experience pain during treatment
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their pain from 1 to 5 where 1=no pain, 2= very mild, 3=mild, 4=moderate (requiring pain medication), 5=severe (requiring pain medication or physician contact). The number of participants with scores of 2 or higher will be divided by all participants.
Measured: 3 months
Severity of pain during treatment
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their pain from 1 to 5 where 1=no pain, 2= very mild, 3=mild, 4=moderate (requiring pain medication), 5=severe (requiring pain medication or physician contact). Mean pain ratings will be calculated with higher mean scores suggesting more severe pain.
Measured: 3 months
Percent of participants that experience redness during treatment
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their overall redness from 1 to 5 where 1=no redness, 2= very minimal, 3=minimal, 4=moderate, 5=severe. The number of participants with scores of 2 or higher will be divided by all participants.
Measured: 3 months
Severity of redness during treatment
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their overall redness from 1 to 5 where 1=no redness, 2= very minimal, 3=minimal, 4=moderate, 5=severe. Mean redness ratings will be calculated with higher mean scores suggesting more severe redness.
Measured: 3 months
Day of worst redness
For participants who experienced any redness, the mean day after treatment when the redness was worst will be calculated.
Measured: 3 months
Percent of participants who experienced scaling/flaking
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any scaling/flaking. The number of participants who responded 'yes' will be divided by all participants.
Measured: 3 months
Percent of participants who experienced skin itching
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any skin itching. The number of participants who responded 'yes' will be divided by all participants.
Measured: 3 months
Percent of participants who experienced skin burning
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any skin burning. The number of participants who responded 'yes' will be divided by all participants.
Measured: 3 months
Participant compliance with treatment
Compliance with treatment will be assessed by weighing the medicine tubes after treatment completion and comparing the weight, estimated in grams from fingertip units (FTU), with the expected weight based on the how much medicine should have been used given the treatment regimen. The closer this difference is to zero, the greater the compliance.
Measured: 3 months
Participant satisfaction with treatment
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their satisfaction with the treatment from 1 to 5 where 1=very dissatisfied, 2= dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied. Mean satisfaction ratings will be calculated with higher mean scores suggesting more treatment satisfaction.
Measured: 3 months
Recurrence rate of cancer lesions at 1 year
The recurrence rate is the percentage of cancer lesions that recur which is the number that recur out of the number cleared.
Measured: 1 year
Recurrence rate of cancer lesions at 3 years
The recurrence rate is the percentage of cancer lesions that recur which is the number that recur out of the number cleared.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start15 Oct 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bilal Fawaz, MD, Principal investigator, Dermatology, Boston University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381597
- Sponsor's protocol ID
- H-42421
- Status last verified
- Nov 2025
- First submitted
- 15 May 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ
- ClinicalTrials.gov ID
- NCT05381597
- Acronym / sponsor ID
- H-42421
- Keywords
- 5-fluorouracil cream, fluorouracil with calcipotriene
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 May 2022 (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 investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers.
The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with
The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination cream of 5-fluorouracil and calcipotriene | Experimental | Drug: Combination cream of 5-fluorouracil and calcipotrieneParticipants randomized to this group will receive treatment with the combination cream consisting of 5-fluorouracil and calcipotriene twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days. |
| 5-fluorouracil cream | Active comparator | Drug: 5-fluorouracil creamParticipants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English-speaking
- Having a previously untreated, biopsy-proven Superficial Basal Cell Carcinoma (sBCC) or Squamous Cell Carcinoma in Situ (SCCis) of the skin <2 cm on the scalp, trunk, neck, or extremities, excluding hands, feet, and genitalia
- Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical candidates
- Willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits
- Participants may have multiple lesions enrolled in the study so long as the individual lesions are greater than 2 cm from each other
Key exclusion criteria (15 listed)
- Current or prior field treatment within 2 cm of the target BCC or SCCis
- Periorbital lesions
- Lesions that have been previously treated
- Known allergy to any of the study medication ingredients
- History of solid organ transplant or current immunosuppression
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 |
|---|---|---|
| Combination cream of 5-fluorouracil and calcipotrieneAlso: compounded creamApply the cream to the size of the lesion extending to the 0.5 cm area of skin surrounding the lesion.twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days. | Drug | Combination cream of 5-fluorouracil and calcipotriene |
| 5-fluorouracil creamAlso: usual treatmentApply the cream to the size of their lesion extending to the 0.5 cm area of skin surrounding the lesion twice daily for 28 days. | Drug | 5-fluorouracil cream |
Primary outcome
Clearance rate of cancer lesions at 3 months
Time frame: 3 months
Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
Clearance rate of cancer lesions at 3 years
Time frame: 3 years
Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
12 secondary outcomes
Percent of participants that experience pain during treatment
Time frame: 3 months
Severity of pain during treatment
Time frame: 3 months
Percent of participants that experience redness during treatment
Time frame: 3 months
Severity of redness during treatment
Time frame: 3 months
Day of worst redness
Time frame: 3 months
Percent of participants who experienced scaling/flaking
Time frame: 3 months
Percent of participants who experienced skin itching
Time frame: 3 months
Percent of participants who experienced skin burning
Time frame: 3 months
Participant compliance with treatment
Time frame: 3 months
Participant satisfaction with treatment
Time frame: 3 months
Recurrence rate of cancer lesions at 1 year
Time frame: 1 year
Recurrence rate of cancer lesions at 3 years
Time frame: 3 years
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 28 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Bilal Fawaz, MD principal investigator
Dermatology, Boston University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Combination cream of 5-fluorouracil and calcipotriene and 5-fluorouracil cream in people with Superficial Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ, run by Boston University 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 6 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Frederick Gibson, MD ((617) 358-9700, frederick.gibson@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance rate of cancer lesions at 3 months (time frame: 3 months). 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 28 Nov 2025.