Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05381597 · ClinicalTrials.gov registry record · Phase 2
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
A Phase 2 study of Superficial Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ, sponsored by Boston University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05381597 is a Phase 2 study of Superficial Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ that is actively recruiting participants, run by Boston University. The registered enrollment target is 200 participants, above the 76-participant average among 5 other Superficial Basal Cell Carcinoma trials with a reported enrollment target (163% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05381597, a Phase 2 study of Superficial Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ, is actively recruiting participants, sponsored by Boston University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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). 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.
Conditions Studied
Interventions
- DRUG Combination cream of 5-fluorouracil and calcipotriene
- DRUG 5-fluorouracil cream
Study Locations (1)
Massachusetts
- Boston Medical Center Dermatology Clinic - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-10-15 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05381597
The ClinicalTrials.gov registry entry for NCT05381597 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 76-participant average among 5 other Superficial Basal Cell Carcinoma trials with a reported enrollment target (163% higher). The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Superficial Basal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Combination cream of 5-fluorouracil and calcipotriene is the first listed.
NCT05381597 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05381597 about?
NCT05381597 is a clinical study titled "5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer". 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 ...
What is the current status of trial NCT05381597?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2022-10-15. Estimated completion is 2027-06.
What conditions does trial NCT05381597 study?
This clinical trial studies the following conditions: Superficial Basal Cell Carcinoma, Squamous Cell Carcinoma in Situ.
What interventions are being tested in trial NCT05381597?
The interventions under investigation include: Combination cream of 5-fluorouracil and calcipotriene (DRUG), 5-fluorouracil cream (DRUG).
Who is sponsoring clinical trial NCT05381597?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05381597 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Superficial Basal Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults
COMPLETED · Phase 2
-
To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC
COMPLETED · Phase 2
-
A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
RECRUITING · Phase 1
-
Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
RECRUITING · NA
-
Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
ACTIVE NOT RECRUITING · Phase 3
Explore more on PlainTrial
Superficial Basal Cell Carcinoma
All registered trials for this condition
Squamous Cell Carcinoma in Situ
All registered trials for this condition
Massachusetts
All trials with a study site in Massachusetts
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.