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New treatment option for Superficial Basal Cell Carcinoma
Official title 5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
ClinicalTrials.gov ID: NCT05381597
What this study is testing
What is Combination cream of 5-fluorouracil and calcipotriene?
Combination cream of 5-fluorouracil and calcipotriene is an investigational medicine, given as a twice-daily treatment applied to the skin, being studied as a potential treatment for superficial basal cell carcinoma.
Also referred to as compounded cream.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical...
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.