Today, we will be looking into the latest research and clinical trials focused on basal cell carcinoma in adults.

The following list has been carefully curated by evaluating the ongoing phase 3 trials for basal cell carcinoma, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.

This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.

Now, let’s go ahead and explore the list of Basal Cell Carcinoma Clinical Trials!

Quick View Table of Basal Cell Carcinoma Clinical Trials
Study TitlePhaseEnrollmentStart DateLast Update Posted
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin CancerPHASE 3200 10/15/202212/24/2024
Basal Cell Carcinoma Chemoprevention Trial (B3C)PHASE 316306/1/20251/14/2025
Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)PHASE 31086/3/20209/24/2024
Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)PHASE 31742/19/20197/3/2024
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).PHASE 31869/25/20186/26/2024
Photodynamic Therapy (PDT) With Metvix Cream 160 mg/​g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell CarcinomaPHASE 36512/1/20008/5/2024

Phase 3 Clinical Trials:

5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer

Study Details | Source

  • Sponsor: Boston University
  • 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.
  • Interventions:
    • Drug: Combination cream of 5-fluorouracil and calcipotriene
    • Drug: 5-fluorouracil cream
  • Primary Outcomes Measures:
    • Clearance rate of cancer lesions at 3 months
      • Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
    • Clearance rate of cancer lesions at 3 years
      • Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.

Basal Cell Carcinoma Chemoprevention Trial (B3C)

Study Details | Source

  • Sponsor: VA Office of Research and Development
  • 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. Participants will apply the IMQ or placebo cream to the face daily at bedtime for 12 weeks. This study will recruit 1630 Veterans at high risk of BCC from 17 VA medical centers.
  • Interventions:
    • Drug: 5% Imiquimod cream
    • Drug: Placebo Vehicle Control Cream
  • Primary Outcomes Measures:
    • Proportion of participants with a new Basal Cell Carcinoma (BCC) on the face at 1 year
      • Skin exams will occur at baseline and at 6-month intervals after study randomization. Diagnosis of a new BCC will be ascertained by a biopsy under local anesthesia in an outpatient setting, as is the standard of care. Every biopsy performed on the face of a participant during the trial will be processed per standard clinical operating procedures, as determined by their blinded clinician for the purposes of patient management. The biopsy will be sent for reading by a blinded central dermatopathologist with known high reliability (intra-rater and inter-rater with two other board-certified dermatopathologists) for diagnosing BCC. This central dermatopathologist diagnosis will be used for study purposes. Skin cancers diagnosed outside of the VA, and associated surgeries, will be systematically sought in all participants by participant interview and review of medical records to ensure that the outcome measure is complete.
    • Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years
      • Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years is defined as the time in years from treatment randomization to the first occurrence of a new BCC on the face. Participants who do not develop a new BCC on the face by 3 years will be considered censored observations. Skin exams will occur at baseline and at 6-month intervals after study randomization.

Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)

Study Details | Source

  • Sponsor: Sol-Gel Technologies, Ltd.
  • This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.
  • Interventions:
    • Drug: Patidegib Topical Gel, 2%
  • Primary Outcomes Measures:
    • Incidence of Treatment-emergent Adverse Events (TEAEs)
      • IMP=Investigational medicinal product; Unique adverse event = adverse event of a certain preferred term, counted only once within each subject.
      • Related adverse event = adverse event with relationship as Definitely, Probably or Possibly.

Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)

Study Details | Source

  • Sponsor: Sol-Gel Technologies, Ltd.
  • This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.
  • Interventions:
    • Drug: Patidegib Topical Gel, 2%
    • Drug: Patidegib Topical Gel, Vehicle
  • Primary Outcomes Measures:
    • Number of New BCCs Per Participant
      • Time Frame - Month 12

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).

Study Details | Source

  • Sponsor: Biofrontera Bioscience GmbH
  • 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:
    • Combination Product: Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)
    • Combination Product: Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
  • Primary Outcomes Measures:
    • 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.
      • The composite clinical and histological response rate of the subject's Main Target Lesion is the percentage of subjects with clinically and histologically cleared Main Target lesion 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion (Visit 5 or Visit 8).

Photodynamic Therapy (PDT) With Metvix Cream 160 mg/​g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma

Study Details | Source

  • Sponsor: Galderma R&D
  • Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination.
  • For skin diseases, there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix, contained the methyl ester of ALA, which penetrated the lesions well and shows high lesion selectivity.
  • In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix. The increased photoactive porphyrins levels induced cytotoxic effects in tumour cells after photoactivation.
  • The primary objective was to compare PDT with Metvix cream to PDT with placebo cream in terms of participants complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle. Secondary objectives was to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant, lesion response rates across participants, clinical complete participant response, cosmetic outcome and adverse events.
  • Interventions:
    • Radiation: Photodynamic Therapy (PDT)
    • Drug: Metvix cream
    • Drug: Placebo Cream
  • Primary Outcomes Measures:
    • Number of Participants With Histologically Confirmed Complete Response
      • The histological complete response was defined as 100 percent (%) of the lesions within the participant having negative findings in the histological examination. Histological examination included evaluation of all the microscopical slides from the excised tissue for presence of malignant basal cells. Complete response was defined as complete disappearance of lesion. Number of participants with histologically confirmed complete response were reported.
      • Time frame - up to 9 months
Potential Guidelines That May Be Affected Include:

There you have it - a list of phase 3 clinical trials for age-related macular degeneration as of January 2025. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.

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