Open-Label Proof of Concept Study of VP-315 in Basal Cell Carcinoma

A Phase 2, Multicenter, Open-label, Proof-of-concept Study With Safety Run-in to Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in Adult Subjects With Basal Cell Carcinoma

This is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, MTD, and objective antitumor efficacy of ascending dose strengths of VP-315 when administered intratumorally to adults with biopsy proven basal cell carcinoma (BCC).

The study is expected to enroll approximately 86 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).

Study Overview

• Status: Completed
• Conditions: Carcinoma; Skin Cancer; Basal Cell Carcinoma; Cancer of the Skin, Basal Cell; Cancer of the Skin
• Intervention / Treatment: Drug: Part 1: VP-315 3 Day Dosing/Week; Drug: Part 2: VP-315 3 Day Dosing/Week - Loading Dose; Drug: Part 2: VP-315 3 Day Dosing/Week - No Loading Dose; Drug: Part 2: VP-315 2 Day Dosing/Week - Split Dose; Drug: Part 2: VP-315 3 Day Dosing/Week - Split Dose

Detailed Description

This is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, maximum tolerated dose (MTD), and objective antitumor efficacy of ascending dose strengths of VP-315 when administered intratumorally to adults with biopsy proven BCC.

The study is expected to enroll approximately 86 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).

All enrolled subjects will receive VP-315 intradermal injection on an outpatient basis into up to 2 target lesions. In all Parts of the study (1 or 2, as below), each 7-day treatment week comprises up to 3 consecutive treatment days followed by a no-treatment period of at least 4 days. Dosing will commence in a single target lesion. Once a lesion is observed to be fully necrotic (Part 1, Part 2; Cohorts 1-2 only), treatment of that lesion stops, and treatment of subsequent target lesions (up to 2 total) may continue on Day 1 of the following week. In Part 2, Cohorts 4 and 5, treatment of a second target lesion begins on W2D1 (not based on status of necrosis of target lesion 1).

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Florida
    • Boca Raton, Florida, United States, 33428
      • ClearlyDerm
    • Coral Springs, Florida, United States, 33071
      • LIFE Clinical Trials
    • Saint Augustine, Florida, United States, 32080
      • Florida Center for Dermatology
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Gwinnett Dermatology
  • Illinois
    • Oakbrook Terrace, Illinois, United States, 60181
      • Affinity Health
  • Maryland
    • Rockville, Maryland, United States, 20850
      • DermAssociates
    • Rockville, Maryland, United States, 20850
      • Lawrence J Green, MD LLC
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Research - Borthwick
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC St. Margaret
  • Texas
    • Dripping Springs, Texas, United States, 78620
      • Austin Institute of Clinical Research - Dripping Springs
    • Houston, Texas, United States, 77056
      • Austin Institute of Clinical Research - Houston
    • Pflugerville, Texas, United States, 78660
      • Austin Institute of Clinical Research - Pflugerville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults ≥18 years of age
2. Clinically suspected BCC with at least 1 and up to 5 eligible lesion(s) suitable for biopsy and excision
3. Willing to refrain from using nonapproved topical agents on, or within 2 cm of, the target BCC lesions and surrounding areas during the treatment period. Subjects should use topical agents that are gentle (eg, Aquaphor, CeraVe) and will not irritate the skin in these areas.
4. Willing to refrain from exposure to direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study
5. Written informed consent obtained, including consent for tissue to be examined by the central dermatopathologist and stored by the Sponsor or designee
6. Willing to undergo BCC surgical excision procedure of target and nontarget BCC lesions after study treatment
7. Willing to delay surgical excision of target and nontarget BCC lesions until the end of treatment (EOT) visit
8. Provides written consent to allow photographs of the target and nontarget BCC lesion to be used as part of the study data
9. Willing to practice a highly effective method of birth control while on study and until 4 weeks after the last treatment. Highly effective birth control includes sexual abstinence, vasectomy, bilateral tubal ligation/occlusion, or a condom with spermicide (men) combined with hormonal birth control or intrauterine device in women.

BCC Lesion Eligibility

Eligible lesions are those that meet the BCC lesion eligibility specifications described herein, from samples that are either from:

• HISTORICAL punch or shave biopsies (i.e., samples collected according to clinical standard of care collected within the 90 days prior to W1D1);
• A 2-mm punch biopsy collected within 90 days of W1D1 for suspected BCC ≥0.5 cm to 1.0 cm, and 3-mm punch biopsy for suspected BCC >1.0 cm to 2.0 cm; or
• A shave biopsy performed according to standard of care to include superficial or middle papillary dermis collected within 90 days of W1D1.

Lesions must meet the following criteria to be eligible for treatment

BCC Lesion Inclusion Criteria

1. For punch biopsies: the size of the lesion(s) must be ≥0.5 cm and </=2 cm in the longest diameter prior to punch biopsy.
2. Histological diagnosis of nodular, micronodular, or superficial BCC, as confirmed by punch or shave biopsy performed within 90 days of W1D1. (NOTE: HISTORICAL punch or shave biopsies are acceptable, provided that the biopsy was performed according to clinical standard of care and was collected within the 90 days prior to Screening.) Subject Exclusion Criteria Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.

Exclusion Criteria

1. Presence of known or suspected systemic cancer
2. Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit
3. Treatment with systemic immunotherapy, immunomodulators or immunosuppressants within the 12 weeks prior to the screening period
4. Genetic or nevoid conditions (eg, Gorlin / basal cell nevus syndrome, xeroderma pigmentosum)

5. Clinically significant laboratory values, as assessed by the investigator, for the tests listed in the Schedule of Assessments, including:

   1. serum creatinine >1.5× the upper limits of normal and
   2. serum tryptase concentration >11.4 ng/mL

6. Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the subject at undue risk, such as, but not limited to:

   1. Uncontrolled infection or infection requiring antibiotics
   2. Uncontrolled cardiac failure: Classification III or IV New York Heart Association
   3. Subjects presenting with a systolic BP <110 mmHg and/or diastolic BP <70 mmHg at Screening or Week 1 Day 1 or a history of cerebrovascular or cardiac disorders, or subjects at particular risk of sequelae following a short hypotensive episode.
   4. Uncontrolled systemic or gastrointestinal inflammatory conditions
   5. Known bone marrow dysplasia
   6. History of positive tests for human immunodeficiency virus/acquired immunodeficiency syndrome or active hepatitis B or C
   7. History of systemic autoimmune disease requiring anti-inflammatory or immunosuppressive therapy within 3 months prior to Day 1, with the following exceptions:

   i. Subjects with a history of autoimmune thyroiditis are eligible provided the subject requires only thyroid hormone replacement therapy and disease has been stable for ≥1 year

   ii. Subjects with well-controlled type I diabetes (in the opinion of the investigator) are eligible

   h. Known mast cell activation syndrome, mastocytosis, or chronic idiopathic urticaria

7. Known sensitivity to any of the ingredients in the study medication
8. Elective surgery within 4 weeks prior to the screening visit, during the study, or 4 weeks after the treatment period
9. Evidence of current chronic alcohol or drug abuse
10. Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit
11. In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study
12. Females who are pregnant or breastfeeding

BCC Lesion Exclusion Criteria

1. Recurrent or previously treated lesions
2. Lesions within 1 cm of the eyelids or lips, or on the hands, feet, ears, nose, and genitalia
3. Histological evidence of any other tumor in the biopsy specimen
4. Histological evidence of infiltrative, desmoplastic, sclerosing, or morpheaform BCC subtypes in the biopsy specimen

5. Medium- and high-risk basal cell carcinomas as defined by the National Comprehensive Cancer Network (NCCN) or Mohs Appropriate Use Criteria (ie, BCCs eligible for Mohs surgery).

   TARGET LESION EXCLUSION ONLY:

6. For subjects with severe stasis dermatitis, target BCC lesions may not be on the lower extremities

7. Within 2 cm of the target BCC lesion(s):

   1. Treatment with the following topical agents within the 12 weeks prior to the screening visit: aminolevulinic acid, 5-fluorouracil, corticosteroids, diclofenac, imiquimod, ingenol mebutate
   2. Treatment with surgical excision, or curettage within the 2 weeks prior to the screening visit
   3. Evidence of dermatological disease or confounding skin condition that may interfere with clinical evaluation (ie, psoriasis, atopic dermatitis, eczema, propensity to form keloids or hypertrophic scarring)
   4. Use of topical immunomodulators during study
8. Within 5 cm of the target BCC lesion(s): history of any skin cancer, except for other currently identified target and nontarget BCC lesions
9. Target BCC lesion is in the area of prior resurfacing procedure with CO2 laser or any photodynamic and phototherapy treatment within the 3 months prior to the screening visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 - Cohort 1: Dose Escalation VP-315 2 mg; Cohort 1: Starting total daily dose of VP-315 will be 2 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.	Drug: Part 1: VP-315 3 Day Dosing/Week; 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
Experimental: Part 1 - Cohort 2: Dose Escalation VP-315 3 mg; Cohort 2: Starting total daily dose of VP-315 will be 3 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 3 mg on Day 1, 4 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.	Drug: Part 1: VP-315 3 Day Dosing/Week; 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
Experimental: Part 1 - Cohort 3: Dose Escalation VP-315 4 mg; Cohort 3: Starting total daily dose of VP-315 will be 4 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 4 mg on Day 1, 5 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.	Drug: Part 1: VP-315 3 Day Dosing/Week; 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
Experimental: Part 1 - Cohort 4: Dose Escalation VP-315 5 mg; Cohort 4: Starting total daily dose of VP-315 will be 5 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 5 mg on Day 1, 6 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.	Drug: Part 1: VP-315 3 Day Dosing/Week; 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
Experimental: Part 1 - Cohort 5: Dose Escalation VP-315 6 mg; Cohort 5: Starting total daily dose of VP-315 will be 6 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 6 mg on Day 1, 7 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.	Drug: Part 1: VP-315 3 Day Dosing/Week; 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
Experimental: Part 1 - Cohort 6: Dose Escalation VP-315 7 mg; Cohort 6: Starting total daily dose of VP-315 will be 7 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 7 mg on Day 1, 8 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.	Drug: Part 1: VP-315 3 Day Dosing/Week; 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
Experimental: Part 1 - Cohort 7: Dose Escalation VP-315 8 mg; Cohort 7: Starting total daily dose of VP-315 will be 8 mg. Subjects will receive once daily doses of 8 mg for up to 3 days in a 7-day treatment week (e.g., 8 mg on Day 1, 8 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.	Drug: Part 1: VP-315 3 Day Dosing/Week; 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
Experimental: Part 2 - Cohort 1: Optimal Dosing Regimen of 3 daily doses of VP-315, 4 mg loading dose; VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).	Drug: Part 2: VP-315 3 Day Dosing/Week - Loading Dose; 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
Experimental: Part 2 - Cohort 2: Optimal Dosing Regimen of 3 daily doses of VP-315 no loading dose; VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).	Drug: Part 2: VP-315 3 Day Dosing/Week - No Loading Dose; 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Experimental: Part 2 - Cohort 4: Optimal Dosing Regimen of 2 daily doses of VP-315 8 mg (split dose); VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.	Drug: Part 2: VP-315 2 Day Dosing/Week - Split Dose; 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Experimental: Part 2 - Cohort 5: Optimal Dosing Regimen of 3 daily doses of VP-315 8 mg (split dose); VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.	Drug: Part 2: VP-315 3 Day Dosing/Week - Split Dose; 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Percentage of Subjects With Discontinuations Due to Adverse Events	Part 1: Percentage of subjects that discontinued the study due to adverse event	Up to 9 weeks
Part 1: Percentage of Subjects With Dose-limiting Toxicities (DLTs)	Subjects with pre-determined dose-limiting toxicities such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria)	Day 4 (Safety Assessment)
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity	Cutaneous injection site reactions are defined as the following preferred terms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site exfoliation, Injection site erosion, Injection site ulcer, Injection site necrosis. The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA. Subjects having more than one event may appear in more than one System Organ Class or Preferred Term but are counted at most once per each SOC and PT at the maximum severity. Cutaneous injection site reactions are types of reactions that can be expected to occur.	Up to 9 weeks
Part 2: Percent of Subjects With Adverse Events	Part 2: Percent of subjects with adverse events, treatment-related AEs	Up to 15 weeks
Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events	Part 2: Percentage of subjects with study discontinuations due to adverse events.	Up to 15 weeks
Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)	Subjects with pre-determined TRAEs of SI such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria)	Treatment Days up to 2 weeks
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity	Evaluation of the tissue condition at the treatment site for the presence and severity of each of the following cutaneous reactions; Erythema, Induration, Swelling, Blister Formation, Desquamation, Erosion, Ulceration, Necrosis by a scale of None; Mild; Moderate; Severe. Subjects having more than one event may appear in more than one SOC or PT but are counted at most once per each SOC and PT at the maximum severity. Cutaneous injection site reactions are types of reactions that can be expected to occur. The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA	Up to 105 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision	Clinical clearance of Target Lesion at excision as determined by visual assessment (no residual tumor seen on visual inspection). Clinical assessment using Physician Global Assessment (PGA). PGA scale: 100% Improvement, no visible tumor; 75% to less than 100% improvement, 50% to less than 75% improvement, 25% to less than 50% improvement, Up to 25% improvement, No change, Worse.	Day 84-91
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision	Percentage of Subjects with histological clearance of treated lesion(s) at excision. Histologic clearance confirmed by central dermatopathologist. Percentage is calculated using the number of subjects with non-missing responses within lesion as the denominator. *Scar indicates complete histologic clearance	Day 84-91
Part 2: Mean Estimated Remaining Tumor Volume at Excision	Estimate of remaining tumor volume (necrotic cells:tumor cells) at excision by central dermatopathologist Scale: 0 = None Remaining to 100 = All Remaining.	Day 84-91
Part 2 (Cohorts 4 and 5 Expansion Groups): Plasma Concentrations of VP-315	Pharmacokinetics (PK) of an 8 mg dose of VP-315 administered with the optimal dosing regimen	Day 1-2

Collaborators and Investigators

• Sponsor: Verrica Pharmaceuticals Inc.
• Collaborators: Q2 Solutions; Instat Clinical Research; HeartcoR Solutions; Myonex; Vial Health Technology, Inc; OncoBay Clinical; Canfield Scientific; Veristat
• Investigators: Principal Investigator: Neal Bhatia, MD, Therapeutics Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Skin Cancer; Neoplasm; Epithelial; BCC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Neoplasms, Basal Cell; Carcinoma; Skin Neoplasms; Carcinoma, Basal Cell
• Other Study ID Numbers: VP-315-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No