Adults with superficial basal cell carcinoma now have an FDA-approved, nonsurgical treatment that uses a medicated gel activated by red light. The agency approved Ameluz topical gel used with the BF-RhodoLED lamp for this skin cancer subtype; manufacturer Biofrontera announced on September 14 that it is the first photodynamic therapy drug approved in the United States to treat a skin cancer, according to the company's release.
Basal cell carcinoma is the most common skin cancer in the country, with about 3.6 million cases diagnosed each year, according to Skin Cancer Foundation figures cited by the company. Biofrontera estimates the superficial subtype accounts for 15% to 20% of those cases, or roughly 540,000 to 720,000 a year. Superficial lesions often appear on the trunk, arms, or legs, and patients frequently have more than one.
For patients with several lesions, or with spots where a scar would be a concern, the approval adds an in-office option. It does not replace surgery for most basal cell cancers, and it does not apply to other subtypes.
Trial Results Behind the Approval
The decision rests on a randomized, double-blind Phase 3 trial registered as NCT03573401 of 187 adults with biopsy-confirmed superficial basal cell carcinoma at 21 U.S. centers. Participants received one or two treatment cycles, each made up of two sessions given 7 to 14 days apart, and were assessed 12 weeks after the start of their last cycle. The results were published in the peer-reviewed Journal of the American Academy of Dermatology in August 2025, HealthDay reported. The first author is Dr. Todd Schlesinger, a dermatologist and Mohs surgeon in South Carolina.
The treatment works in steps. A clinician prepares the lesion, applies the gel, and covers it for about three hours while abnormal cells absorb the drug. The area is then exposed to red light, which triggers a reaction that damages those cells.
The main goal required the primary lesion to be gone both on visual exam and under the microscope. That happened in 66% of patients treated with Ameluz, or 95 of 145, compared with 5% of those given an inactive gel with the same light, or 2 of 42. Microscopic clearance of the main lesion occurred in 76% versus 19%, and 83% of Ameluz patients had every target lesion look clear, compared with 21%.
Pain at the treatment site was the most common side effect, reported by 95% of Ameluz patients and sometimes severe, according to the updated prescribing information. Redness, itching, and swelling were also common. Treated skin must be protected from sunlight for about 48 hours, and the label warns of rare allergic reactions and temporary memory loss reported after treatment.
Dr. M. Shane Chapman, founding chair of dermatology at Dartmouth Hitchcock Medical Center and a key contributor to the trial, called the approval "a rigorously studied, non-surgical option that we can deliver in our office." He said it may help patients with multiple lesions, lesions in cosmetically sensitive areas, or those who prefer to avoid surgery.
A Nonsurgical Option with Real Limits
The evidence has limits readers should weigh. The trial was sponsored by Biofrontera, and several authors work for the company. The placebo group was small, with 42 people; all participants were White, and the main result was measured at 12 weeks, so the data do not show how often tumors return over years. The label also notes that 22% of Ameluz patients whose target lesions looked clear still had cancer cells found under the microscope. The study's authors note that surgery remains the gold standard for basal cell carcinoma, even though it often leaves cosmetic defects.
Patients also have other nonsurgical options. Prescription creams such as imiquimod and fluorouracil are already used for superficial basal cell carcinoma, and a 2013 Dutch randomized trial found imiquimod worked better than photodynamic therapy using a different light-sensitizing drug. No head-to-head comparison between Ameluz and those creams was part of this approval.
It is equally important to understand what this therapy is not. Ameluz treatment combines a prescription drug with a specific medical lamp in a dermatology office. It is not the same as red-light masks, panels, or wands sold to consumers, and none of those products is approved to treat skin cancer.
People who may be most affected include older adults with years of sun exposure, patients with many superficial lesions, and those for whom surgery carries added risk. Warning signs of basal cell carcinoma can include a pink or red scaly patch, a shiny bump, or a sore that bleeds, crusts, or does not heal. Anyone with a new or changing spot should have it checked by a clinician, since only a biopsy can confirm the subtype that determines treatment.
Access Will Depend on Dermatology Offices and Coverage
Biofrontera plans a formal launch between late in the fourth quarter of 2026 and the first quarter of 2027, using its existing sales team and the lamps already installed for treating actinic keratosis, a precancerous skin condition the drug was already approved to treat. Practices without the lamp would need to buy one, so availability may be uneven, especially where dermatologists are scarce.
The company has not announced a price, and insurers have not published coverage policies for the new use. Patients should ask whether their plan requires prior authorization and what out-of-pocket costs apply for both the drug and the in-office light sessions. Those without insurance can ask about manufacturer assistance or lower-cost options such as surgery or prescription creams.
Before choosing treatment, patients can ask their dermatologist whether the lesion is confirmed as superficial, how the risk of recurrence compares across options, and how many visits each approach requires. The label calls for a follow-up exam 4 to 6 weeks after each cycle, and routine skin checks every 6 to 12 months. Long-term recurrence data and real-world results will show how the therapy compares with established treatments, and MedicalDaily will report on coverage decisions and follow-up findings as they emerge.
Key Questions Answered
What did the FDA approve? Ameluz topical gel used with the BF-RhodoLED red-light lamp for adults with superficial basal cell carcinoma. It was already approved for actinic keratosis.
How well did it work in the trial? The main lesion cleared both visibly and under the microscope in 66% of Ameluz patients 12 weeks after their last treatment cycle, compared with 5% of patients who received an inactive gel.
What are the main side effects? Pain at the treatment site was reported by 95% of Ameluz patients and can be severe. Redness, itching, and swelling were also common, and treated skin must be kept out of sunlight for about 48 hours.
Can I use a home red-light device instead? No. Consumer red-light devices are not approved to treat skin cancer. This therapy requires a prescription gel and a medical lamp used in a clinic.
Who might be a candidate? Adults with biopsy-confirmed superficial basal cell carcinoma, particularly those with multiple lesions or cosmetic concerns. A dermatologist decides based on the tumor's type and location.
When will it be available? Biofrontera plans an official launch between late 2026 and early 2027. Pricing and insurance coverage have not been announced.
