As the most common form of skin cancer, basal cell carcinoma (BCC) affects millions of Americans each year. It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.
Today, we're taking a look at a trio of Phase 3 trials on BCC that are active or upcoming in the United States.
Quick View Table of Basal Cell Carcinoma Clinical Trials
| Study Title | Recruiting? | Estimated Enrollment | Start Date | Estimated Completion |
|---|---|---|---|---|
| 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) | No | 187 (actual) | September 2018 | February 2029 |
| 5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer | Yes | 200 | October 2022 | June 2027 |
| Basal Cell Carcinoma Chemoprevention Trial (B3C) | Not yet | 1630 | May 2026 (anticipated) | May 2032 |
Phase 3 Clinical Trials on Basal Cell Carcinoma
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).
- Sponsor: Biofrontera
- Goal: The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) with the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for superficial basal cell carcinoma (BCC).
- Interventions: Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT), Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
- Primary Outcome Measure: Composite clinical and histological response of the subject's main target lesion as assessed 12 weeks after the start of the last pdt cycle that included treatment of the main target lesion.
- Time Frame: 12 weeks after the start of the last PDT cycle that included treatment of the main target lesion.
- Study Details
- Source
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
- Sponsor: Boston University
- Goal: 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).
- Interventions: Combination cream of 5-fluorouracil and calcipotriene, 5-fluorouracil cream
- Primary Outcome Measure: Clearance rate of cancer lesions at three months; Clearance rate of cancer lesions at three years.
- Time Frame: Three months; Three years.
- Study Details
- Source
Basal Cell Carcinoma Chemoprevention Trial (B3C)
- Sponsor: VA Office of Research and Development
- Goal: This is an intent-to-treat, parallel design, multicenter randomized trial and the primary intervention is a double-blind comparison of Imiquimod (IMQ) vs. placebo cream for preventing basal cell carcinoma (BCC) of the skin on the face at one year and over 3 years after therapy.
- Intervention: 5% Imiquimod cream
- Primary Outcome Measure: Proportion of participants with a new basal cell carcinoma (BCC) on the face at one year; BCC free time to a new BCC on the face over three years.
- Time Frame: One year from the time of randomization; Three years from the time of randomization.
- Study Details
- Source
Related Clinical Guidance:
- Appropriate Use Criteria for the Treatment of Basal Cell Carcinoma (BCC) Using Image-Guided Superficial Radiation Therapy
- Dermatology Association of Radiation Therapy, July 2025
- Management of Adults with Basal Cell Carcinoma
- British Association of Dermatologists, November 2021
- Management of Basal Cell Carcinoma
- American Academy of Dermatology, January 2018
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