A new surface-applied brachytherapy device is expanding the treatment options available for selected patients with early-stage non-melanoma skin cancer. CivaDerm™ delivers palladium-103 radiation directly to the tumor and is designed to remain in place for approximately four to five days, potentially reducing the number of visits required compared with conventional radiation therapy. While brachytherapy has an established role in managing selected non-melanoma skin cancers [1-4], clinical evidence specific to CivaDerm™ remains limited and is still developing [6].
Key Takeaways
- CivaDerm™ delivers localized radiation to the tumor. This flexible device incorporates palladium-103 and directs radiation toward the treatment site while shielding the opposite side [7].
- The treatment may substantially reduce the number of visits: UC San Diego Health reports that the device is applied once and removed approximately four to five days later, compared with radiation schedules that may require repeated visits over several weeks [8].
- Brachytherapy is an established treatment modality for selected skin cancers: Published studies have reported high local-control rates and favorable cosmetic outcomes with skin brachytherapy, although much of the evidence is derived from non-randomized studies [1-4].
- CivaDerm™-specific clinical evidence remains limited: A completed pilot study enrolled 10 patients. [6] Larger and longer-term studies will be important to define the device’s role relative to established surgical and radiation treatments.
Non-melanoma skin cancers are among the most frequently diagnosed malignancies in the United States. Basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) account for the overwhelming majority of non-melanoma skin cancers, with an estimated 5.4 million cases diagnosed annually in approximately 3.3 million people in the United States [9].
For many patients, surgical excision or Mohs micrographic surgery remains central to management. Radiation therapy is also an established option for selected lesions, particularly when surgery may be difficult or when preserving tissue and function is important [3,4]. Brachytherapy has been studied as a localized radiation approach because it allows the radiation source to be positioned directly at or near the treatment site, producing a rapid dose fall-off outside the target [2,3].
UC San Diego Health now offers a new clinical application of this principle: CivaDerm™, a US Food and Drug Administration (FDA) cleared, flexible radioactive bandage designed to treat selected early-stage non-melanoma skin cancers [8].
Radiation Delivered Through a Bandage
CivaDerm™ is a radionuclide brachytherapy source incorporating palladium-103 (Pd-103). The FDA cleared the device in 2019 through the 510(k) pathway. FDA documentation identifies CivaDerm™ as a Class II radionuclide brachytherapy source and describes its use of biocompatible materials and bioabsorbable polymers to encapsulate Pd-103 [7].
The concept is straightforward: instead of delivering radiation from an external machine, the radioactive source is placed directly over the tumor. The CivaDerm device provides a localized radiation dose while shielding the opposite side [7]. According to UC San Diego Health, a physician applies the bandage directly to the skin cancer, and it remains in place for about four to five days. The physician then removes it, eliminating the need for patients to return repeatedly to a radiation treatment facility during the treatment course [8]. This represents a different treatment logistics model from conventional external-beam radiation therapy and many HDR brachytherapy regimens, which can require repeated visits over several weeks [1,2,8].
For patients who live far from a radiation oncology center or have difficulty traveling frequently because of mobility limitations, reducing treatment visits may be clinically relevant. UC San Diego Health specifically identifies distance from treatment and mobility limitations among the circumstances in which the approach may be considered [8].
The Brachytherapy Principle
Brachytherapy is not a new radiation treatment concept. The approach has been used for decades across oncology, including in gynecologic, prostate, breast, head and neck, ocular and skin malignancies [3]. For non-melanoma skin cancer, the rationale is particularly relevant to superficial disease. Placing the radiation source close to the tumor can produce a high dose within the treatment volume while allowing radiation exposure to decline relatively rapidly with increasing distance from the source [3,5].
Reviews of skin brachytherapy have reported high rates of local control and generally favorable cosmetic outcomes in selected patients. A 2017 systematic review of HDR brachytherapy for non-melanoma skin cancer reported a median local control rate of approximately 97% across the studies reviewed, with excellent or good cosmetic outcomes reported in 94.8% of cases [2].
A more recent systematic review published in 2022 analyzed 14 full-text studies involving 2,403 patients treated with HDR brachytherapy. Reported local control ranged from 71% to 99%, but the authors emphasized that evidence remains limited and that international guidelines have not universally established brachytherapy as a preferred treatment because randomized comparative trials are lacking [1]. These findings provide clinical context for brachytherapy in skin cancer, but they should not be interpreted as evidence establishing equivalent outcomes for CivaDerm specifically.
What makes CivaDerm™ different?
CivaDerm™ uses Pd-103 in a flexible surface-applied configuration. [7] The clinical application being introduced at UC San Diego Health is focused on selected superficial BCC and cSCC lesions. The health system initially plans to concentrate treatment on sites such as the scalp, neck, arms, legs, and trunk rather than the face [8]. Patient selection is important because the device remains radioactive while in place and requires adherence to radiation-safety precautions [8]. Patients must be able to follow instructions during treatment, including precautions intended to limit radiation exposure to others. The approach therefore should not be viewed simply as a replacement for surgery or conventional radiation therapy. Rather, it adds another modality to the treatment options available for appropriately selected patients.
The Clinical Evidence
An important distinction between the established literature on skin brachytherapy and the evidence specific to CivaDerm is the amount of clinical data available. The registered CivaDerm™ Surface Therapy Pilot Study (NCT04480645) was designed as an early-phase, single-arm study. The study enrolled 10 patients with biopsy-confirmed superficial or nodular BCC or cSCC involving the trunk or extremities. Eligible tumors were less than 3 cm, and the protocol included assessment of grade ≥3 skin toxicity and the radiation dose delivered to the target [6].
The study began in May 2024 and was completed in January 2026. The current ClinicalTrials.gov record identifies the study as completed, but no study results have been posted yet. [6] Such an evidence gap matters because published studies support the broader use of brachytherapy for selected non-melanoma skin cancers [1-4], but the clinical performance of a specific device—including local control, toxicity, wound healing, cosmesis, and longer-term recurrence—requires device-specific clinical data. The current introduction of CivaDerm™ at UC San Diego Health therefore reflects the clinical availability of an FDA-cleared device rather than the completion of a large comparative clinical evidence program. [6-8]
Reducing the Burden of Care
One notable feature of the approach is treatment duration. UC San Diego Health reports that conventional external-beam radiation for selected skin cancers can require daily treatments for approximately three to six weeks. HDR brachytherapy may also require repeated treatment visits, with the institution describing a typical course as twice-weekly treatments for approximately five weeks [8]. CivaDerm™ is instead applied once and removed after several days [8].
This difference could be particularly relevant for patients for whom repeated travel to a radiation oncology center is difficult. Distance, transportation, mobility, and the logistical burden of repeated treatment visits are practical considerations in cancer care, particularly among older adults. UC San Diego Health specifically identifies patients who live far from treatment and those with mobility challenges as potential candidates [8]. At the same time, the shorter treatment schedule does not eliminate the need for careful patient selection and monitoring. Patients must follow instructions while the device is radioactive, including radiation-safety precautions during treatment. UC San Diego Health reports that patients may be asked to stay about six feet from others while the device is in place [8].
Patient Selection Remains Central
The appropriate role of surface brachytherapy depends on tumor characteristics, anatomy, prior treatment, patient factors, and treatment goals. Historically, brachytherapy has been considered particularly useful for selected superficial lesions in locations where tissue preservation is important or where surgery may be difficult [3]. A review published in the Journal of the American Academy of Dermatology described brachytherapy as one treatment option for selected patients with non-melanoma skin cancer and reviewed its clinical applications and outcomes [3].
A large international meta-analysis involving 21,371 patients with T1-T2N0 BCC or SCC compared outcomes reported for conventional excision, Mohs micrographic surgery, external-beam radiation therapy, and brachytherapy. The investigators found low one-year recurrence rates across modalities and reported favorable cosmetic outcomes with brachytherapy [4]. Importantly, however, they cautioned that differences between treatment groups could reflect patient-selection and reporting biases rather than treatment superiority [4]. The evidence therefore supports brachytherapy for selected patients while underscoring why treatment selection must remain individualized.
A New Option Within a Broader Radiation Therapy Landscape
CivaDerm™ is being introduced into UC San Diego Health’s already diverse radiation oncology program. The institution uses both high-dose-rate and low-dose-rate brachytherapy across multiple tumor types. The broader brachytherapy program includes localized radiation applications in gynecologic malignancies, breast cancer, skin cancer, and head and neck cancers. At Jacobs Medical Center, the program also uses radioactive plaques for ocular melanoma and collaborates on placing GammaTiles for selected brain tumors [8].
For non-melanoma skin cancer, the emergence of a surface-applied Pd-103 device adds another way of delivering radiation directly to a superficial tumor. The potential clinical value is not simply the device’s physical design. The more important consideration is how the treatment fits into the patient’s overall care plan: tumor size and location, histology, depth, surgical options, previous treatment, anticipated toxicity, patient mobility, and the ability to comply with radiation-safety instructions all remain relevant.
Next Steps
The introduction of CivaDerm™ shows how brachytherapy continues to evolve from fixed treatment systems and applicators toward more conformal, patient-specific approaches. The underlying principle—placing radiation close to the tumor—is well established [3,5]. The newer development is the ability to deliver that radiation through a flexible surface device that can remain in place for several days [7,8].
For clinicians, the next important questions are evidence-based: how CivaDerm™ performs in larger patient populations, which tumor characteristics are most appropriate for treatment, the rates and severity of acute and late skin toxicity, long-term local control, wound healing and cosmetic outcomes, and how its outcomes compare with established surgical and radiation approaches.
Those data will help define where this technology fits within the broader treatment algorithm for non-melanoma skin cancer. For now, CivaDerm™ is an FDA-cleared brachytherapy option that may reduce treatment visits for carefully selected patients. Its clinical introduction at UC San Diego Health expands the practical options available to radiation oncologists while the device-specific evidence base continues to develop [6-8].
Clinical Trials
CivaDerm™ Surface Therapy Pilot Study – ClinicalTrials.gov ID NCT04480645
References
1. Krzysztofiak T, Kamińska-Winciorek G, Pilśniak A, Wojcieszek P. High dose rate brachytherapy in nonmelanoma skin cancer-Systematic review. Dermatol Ther. 2022 Sep;35(9):e15675. doi: 10.1111/dth.15675. Epub 2022 Jul 22. PMID: 35770511.
2. Delishaj D, Rembielak A, Manfredi B, Ursino S, Pasqualetti F, Laliscia C, Orlandi F, Morganti R, Fabrini MG, Paiar F. Non-melanoma skin cancer treated with high-dose-rate brachytherapy: a review of literature. J Contemp Brachytherapy. 2016 Dec;8(6):533-540. doi: 10.5114/jcb.2016.64112. Epub 2016 Dec 2. PMID: 28115960; PMCID: PMC5241375.
3. Alam M, Nanda S, Mittal BB, Kim NA, Yoo S. The use of brachytherapy in the treatment of nonmelanoma skin cancer: a review. J Am Acad Dermatol. 2011 Aug;65(2):377-388. doi: 10.1016/j.jaad.2010.03.027. Epub 2011 Apr 15. PMID: 21496952.
4. Lee CT, Lehrer EJ, Aphale A, Lango M, Galloway TJ, Zaorsky NG. Surgical excision, Mohs micrographic surgery, external-beam radiotherapy, or brachytherapy for indolent skin cancer: An international meta-analysis of 58 studies with 21,000 patients. Cancer. 2019 Oct 15;125(20):3582-3594. doi: 10.1002/cncr.32371. Epub 2019 Jul 29. PMID: 31355928.
5. Gonzalez-Perez V, Rembielak A, Guinot JL, Jaberi R, Lancellotta V, Walter R, Zuchora A, Budrukkar A, Kovács G, Jürgenliemk-Schulz I, Siebert FA, Tagliaferri L. H&N and Skin (HNS) GEC-ESTRO Working Group critical review of recommendations regarding prescription depth, bolus thickness and maximum dose in skin superficial brachytherapy with flaps and customized moulds. Radiother Oncol. 2022 Oct;175:122-132. doi: 10.1016/j.radonc.2022.08.022. Epub 2022 Aug 27. PMID: 36030932.
6. ClinicalTrials.gov. CivaDerm Surface Therapy Pilot Study. NCT04480645. Updated 2026.
7. U.S. Food and Drug Administration. 510(k) Premarket Notification K191324: CivaDerm. September 20, 2019. Online. Last accessed on September 23, 2026.
8. UC San Diego Health. UC San Diego Health First Hospital with Radioactive Skin Cancer Bandage. September 23, 2026.
9. American Cancer Society. Key Statistics for Basal and Squamous Cell Skin Cancers. 2026.Online. Last accessed on September 23, 2026.
Featured image: © 2026 CivaTech™ Oncology. Used with permission.
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