Bowen's DiseasePhase 1/2NCT04293679
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC
A Phase 1/2 study testing STP705 in people with Bowen's Disease and Cutaneous Squamous Cell Carcinoma in Situ, run by Sirnaomics at 1 site in United States.
Trial summary
This is an open label, dose escalation study to evaluate the safety and efficacy of intralesional injection of STP705 in adult patients with Cutaneous Squamous Cell Carcinoma in situ (isSCC, Bowen's disease). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowen's Disease, Cutaneous Squamous Cell Carcinoma in Situ
- What is being tested?
- STP705
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 21 Oct 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female adult ≥ 18 years of age.
- 2. Primary, histologically confirmed trunk or extremity (non-peri-orbital/-anogenital/-facial/-scalp) isSCC lesion suitable for excision with a minimum diameter of 0.5cm and with a maximum diameter of 2.0cm.
- 3. Histological diagnosis made no more than 6 months prior to the screening visit.
- 4. Histological biopsy removed ≤25% of the original area of the target lesion.
- 5. No other dermatological disease in the isSCC target site or surrounding area, which in the opinion of the investigator, could interfere with the study.
- 6. Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period.
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- 7. Willing to refrain from exposure to excessive direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study.
- 8. Laboratory values for the tests (listed in the Study Schedule) within the reference ranges as defined by the central laboratory, or "out of range" test results that is clinically acceptable to the investigator. Acceptable "out of range" values are generally those within 2 standard deviations of the mean or explainable due to concurrent medications or disease processes.
- 9. Ability to follow study instructions and likely to complete all study requirements.
- 10. Written informed consent obtained, including consent for tissue to be examined and stored by the Central Histology Lab.
- 11. Written consent to allow photographs of the target isSCC lesion to be used as part of the study data and documentation.
- 12. For females of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral / implant/ injectable/ transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy).
Who cannot join
- 1. Pregnant or lactating.
- 2. Presence of known or suspected systemic cancer.
- 3. Histological evidence of nBCC, sBCC, invasive SCC, or any other non-isSCC tumor in the biopsy specimen.
- 4. Histological evidence of severe squamous metaplasia, infiltrative, desomoplastic or micronodular growth patterns in the biopsy specimen.
- 5. History of recurrence of the target isSCC lesion.
- 6. Prior exposure to STP705.
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- 7. Evidence of dermatological disease or confounding skin condition in the treatment area, e.g., BCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa.
- 8. Concurrent disease or treatment that suppresses the immune system;
- 9. Patients with baseline QTC > 480 msec using Frederica's formula
- 10. Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the patient at undue risk.
- 11. Known sensitivity to any of the ingredients in the study medication.
- 12. Use of a tanning beds or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the study.
- 13. Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit.
- 14. Use of systemic retinoids within the 6 months prior to the screening period.
- 15. Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period.
- 16. Use of topical immunomodulators within 2cm of the target isSCC lesion within the 4 weeks prior to the screening period.
- 17. Treatment with the following topical agents within 2cm of the target isSCC lesion within the 4 weeks prior to the screening visit: amino-levulanic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, ingenol mebutate, or imiquimod.
- 18. Treatment with liquid nitrogen, surgical excision (excluding diagnostic incisional biopsy) or curettage within 2cm of the target isSCC lesion during the 4 weeks prior to the screening visit.
- 19. Elective surgery within 4 weeks prior to the screening visit, during the study, or 4 weeks after the study period.
- 20. Evidence of current chronic alcohol or drug abuse.
- 21. Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit.
- 22. In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study.
- 23. Taking any investigational product within 1 month of first dose of STP705.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
About this study
Official title: An Open Label, Dose Escalation Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
This is an open label, dose escalation study to evaluate the safety and efficacy of intralesional injection of STP705 in adult patients with Cutaneous Squamous Cell Carcinoma in situ (isSCC, Bowen's disease). The purpose of this trial is to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as Intralesional injection in subjects with isSCC.
Goals:
- To determine the safe and effective recommended dose of STP705 for the treatment of isSCC.
- Analysis of biomarkers common to isSCC formation pathway including TGF-β1 and COX-2.
Read the detailed description
This open label, dose escalation study is designed to evaluate the safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with cutaneous in situ squamous cell carcinoma (isSCC).
The primary objective of this study is to evaluate the safety, tolerability, and efficacy of various doses of STP705 administered as an Intralesional injection in subjects with cutaneous squamous cell carcinoma in situ skin cancer (isSCC). This study seeks to establish a safe and effective recommended dose of STP705 for the treatment of isSCC. Expression of biomarkers common to the isSCC formation pathway, including TGF-β1 and COX-2, will be evaluated.
The primary endpoint will be the proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT). Histological clearance (HC) will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.
Secondary endpoints will include i) time to histological clearance of treated isSCC lesion over the 6 week treatment period, ii) proportion of participants with complete clinical clearance of treated isSCC lesion based on investigator assessment at the End of Treatment (EOT), iii) time to complete clinical clearance of treated isSCC lesion based on investigator assessment over the 6 week treatment period, and iv) the change in size of the treated isSCC lesion over the 6 week treatment period.
Safety and tolerability will be assessed by the number of incidence of adverse events (AEs) and serious adverse events (SAEs); the incidence of AEs and SAEs leading to discontinuation of trial medication; the incidence and severity of Local Skin Response (LSR); hypopigmentation and hyperpigmentation following treatment; and the tolerability of repeated Intralesional administration of STP705 as assessed by investigator-evaluation of injection site reactions for all patients and within each cohort.
In addition, safety measures will include clinically relevant changes or new abnormal findings in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables.
25 adult patients are planned to be enrolled in the study. They will be divided equally among 5 cohorts (10, 20, 30, 60 and 120 μg dose levels) of 5 subjects each. Enrollment of the first two subjects in each dosing cohort will be staggered by at least 48 hours. Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the isSCC lesion. The participants will receive injections of STP705 once a week for up to 6 weeks. The clinician will evaluate the tumor for clinical changes and reduction in size at each treatment visit for up to 6 weeks. If during the 6 weeks of treatment there is complete clinical clearance of the tumor, the treatments will end. At the End of Treatment visit, the residual tumor, or former tumor location will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.
If any of the SAEs or dose limiting toxicities outlined above has occurred, the Data Safety Monitoring Board (DSMB) will conduct independent review of the data and will make a final decision for dose escalation to the next cohort.
- Being tested
- STP705
- Keywords
- isSCC, Cutaneous Squamous Cell Carcinoma, STP705, Cutaneous Squamous Cell Carcinoma in situ
- Medical subject headings
- Bowen's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP705Drug
Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: STP705 10 μg dose | Experimental | Cohort A: STP705 10 μg dose, intradermal injection, given once a week for up to 6 weeks Receives: Drug: STP705 |
| Cohort B: STP705 20 μg dose | Experimental | Cohort B: STP705 20 μg dose, intradermal injection, given once a week for up to 6 weeks Receives: Drug: STP705 |
| Cohort C: STP705 30 μg dose | Experimental | Cohort C: STP705 30 μg dose, intradermal injection, given once a week for up to 6 weeks Receives: Drug: STP705 |
| Cohort D: STP705 60 μg dose | Experimental | Cohort D: STP705 60 μg dose, intradermal injection, given once a week for up to 6 weeks Receives: Drug: STP705 |
| Cohort E: STP705 120 μg dose | Experimental | Cohort E: STP705 120 μg dose, intradermal injection, given once a week for up to 6 weeks Receives: Drug: STP705 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).
Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).
Histological clearance (HC) will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.
Measured: 6 weeks
Secondary outcomes (4)
Time to histological clearance of treated isSCC lesion over the 6 week treatment period.
Measured: over the 6 week treatment period
Proportion of participants with complete clinical clearance of treated isSCC lesion based on investigator assessment at the End of Treatment (EOT).
Measured: 6 weeks
Time to complete clinical clearance of treated isSCC lesion based on investigator assessment over the 6 week treatment period.
Measured: over the 6 week treatment period
Change in size of the treated isSCC lesion over the 6 week treatment period.
Change in size of the treated isSCC lesion over the 6 week treatment period. A base line assessment of lesion size will be made by investigator at T1 (first visit, Day 0). The change in size will be assessed every week until the surgical excision of isSCC at the End of Treatment visit (EOT, Day 42) .
Measured: over the 6 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start21 Mar 2019
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowen's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the isSCC lesion. The participants will receive injections of STP705 once a week for up to 6 weeks. The clinician will evaluate the tumor for clinical changes and reduction in size at each treatment visit for up to 6 weeks. If during the 6 weeks of treatment there is Complete Clinical Clearance of the tumor, the treatments will end. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirnaomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
- Investigators
- Kush Dhody, MBBS, MS, CCRA, Study director, Amarex Clinical Research, LLC (Amarex)Brian Berman, MD, PhD, Principal investigator, Center for Clinical and Cosmetic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293679
- Sponsor's protocol ID
- SRN-705-004
- Status last verified
- Dec 2020
- First submitted
- 26 Feb 2020
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kuzbicki L, Brozyna AA. Expression of Cyclooxygenase-2 in Human Epithelial Skin Lesions: A Systematic Review of Immunohistochemical Studies. Appl Immunohistochem Mol Morphol. 2021 Mar 1;29(3):163-174. doi: 10.1097/PAI.0000000000000871.
PubMed 32889812
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose Escalation Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
- ClinicalTrials.gov ID
- NCT04293679
- Acronym / sponsor ID
- SRN-705-004
- Keywords
- isSCC, Cutaneous Squamous Cell Carcinoma, STP705, Cutaneous Squamous Cell Carcinoma in situ
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- SirnaomicsIndustry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, dose escalation study to evaluate the safety and efficacy of intralesional injection of STP705 in adult patients with Cutaneous Squamous Cell Carcinoma in situ (isSCC, Bowen's disease). The purpose of this trial is to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as Intralesional injection in subjects with isSCC.
Goals:
- To determine the safe and effective recommended dose of STP705 for the treatment of isSCC.
- Analysis of biomarkers common to isSCC formation pathway including TGF-β1 and COX-2.
Detailed description
This open label, dose escalation study is designed to evaluate the safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with cutaneous in situ squamous cell carcinoma (isSCC).
The primary objective of this study is to evaluate the safety, tolerability, and efficacy of various doses of STP705 administered as an Intralesional injection in subjects with cutaneous squamous cell carcinoma in situ skin cancer (isSCC). This study seeks to establish a safe and effective recommended dose of STP705 for the treatment of isSCC. Expression of biomarkers common to the isSCC formation pathway, including TGF-β1 and COX-2, will be evaluated.
The primary endpoint will be the proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT). Histological clearance (HC) will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.
Secondary endpoints will include i) time to histological clearance of treated isSCC lesion over the 6 week treatment period, ii) proportion of participants with complete clinical clearance of treated isSCC lesion based on investigator assessment at the End of Treatment (EOT), iii) time to complete clinical clearance of treated isSCC lesion based on investigator assessment over the 6 week treatment period, and iv) the change in size of the treated isSCC lesion over the 6 week treatment period.
Safety and tolerability will be assessed by the number of incidence of adverse events (AEs) and serious adverse events (SAEs); the incidence of AEs and SAEs leading to discontinuation of trial medication; the incidence and severity of Local Skin Response (LSR); hypopigmentation and hyperpigmentation following treatment; and the tolerability of repeated Intralesional administration of STP705 as assessed by investigator-evaluation of injection site reactions for all patients and within each cohort.
In addition, safety measures will include clinically relevant changes or new abnormal findings in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables.
25 adult patients are planned to be enrolled in the study. They will be divided equally among 5 cohorts (10, 20, 30, 60 and 120 μg dose levels) of 5 subjects each. Enrollment of the first two subjects in each dosing cohort will be staggered by at least 48 hours. Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the isSCC lesion. The participants will receive injections of STP705 once a week for up to 6 weeks. The clinician will evaluate the tumor for clinical changes and reduction in size at each treatment visit for up to 6 weeks. If during the 6 weeks of treatment there is complete clinical clearance of the tumor, the treatments will end. At the End of Treatment visit, the residual tumor, or former tumor location will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.
If any of the SAEs or dose limiting toxicities outlined above has occurred, the Data Safety Monitoring Board (DSMB) will conduct independent review of the data and will make a final decision for dose escalation to the next cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the isSCC lesion. The participants will receive injections of STP705 once a week for up to 6 weeks. The clinician will evaluate the tumor for clinical changes and reduction in size at each treatment visit for up to 6 weeks. If during the 6 weeks of treatment there is Complete Clinical Clearance of the tumor, the treatments will end. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.
| Arm | Type | Receives |
|---|---|---|
| Cohort A: STP705 10 μg dose | Experimental | Drug: STP705Cohort A: STP705 10 μg dose, intradermal injection, given once a week for up to 6 weeks |
| Cohort B: STP705 20 μg dose | Experimental | Drug: STP705Cohort B: STP705 20 μg dose, intradermal injection, given once a week for up to 6 weeks |
| Cohort C: STP705 30 μg dose | Experimental | Drug: STP705Cohort C: STP705 30 μg dose, intradermal injection, given once a week for up to 6 weeks |
| Cohort D: STP705 60 μg dose | Experimental | Drug: STP705Cohort D: STP705 60 μg dose, intradermal injection, given once a week for up to 6 weeks |
| Cohort E: STP705 120 μg dose | Experimental | Drug: STP705Cohort E: STP705 120 μg dose, intradermal injection, given once a week for up to 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Male or female adult ≥ 18 years of age.
- 2. Primary, histologically confirmed trunk or extremity (non-peri-orbital/-anogenital/-facial/-scalp) isSCC lesion suitable for excision with a minimum diameter of 0.5cm and with a maximum diameter of 2.0cm.
- 3. Histological diagnosis made no more than 6 months prior to the screening visit.
- 4. Histological biopsy removed ≤25% of the original area of the target lesion.
- 5. No other dermatological disease in the isSCC target site or surrounding area, which in the opinion of the investigator, could interfere with the study.
Key exclusion criteria (23 listed)
- 1. Pregnant or lactating.
- 2. Presence of known or suspected systemic cancer.
- 3. Histological evidence of nBCC, sBCC, invasive SCC, or any other non-isSCC tumor in the biopsy specimen.
- 4. Histological evidence of severe squamous metaplasia, infiltrative, desomoplastic or micronodular growth patterns in the biopsy specimen.
- 5. History of recurrence of the target isSCC lesion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STP705Investigational Product | Drug | Cohort A: STP705 10 μg dose, Cohort B: STP705 20 μg dose, Cohort C: STP705 30 μg dose, Cohort D: STP705 60 μg dose, Cohort E: STP705 120 μg dose |
Primary outcome
Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).
Time frame: 6 weeks
Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT). Histological clearance (HC) will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.
4 secondary outcomes
Time to histological clearance of treated isSCC lesion over the 6 week treatment period.
Time frame: over the 6 week treatment period
Proportion of participants with complete clinical clearance of treated isSCC lesion based on investigator assessment at the End of Treatment (EOT).
Time frame: 6 weeks
Time to complete clinical clearance of treated isSCC lesion based on investigator assessment over the 6 week treatment period.
Time frame: over the 6 week treatment period
Change in size of the treated isSCC lesion over the 6 week treatment period.
Time frame: over the 6 week treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Derived from this study: PubMed 32889812Kuzbicki L, Brozyna AA. Expression of Cyclooxygenase-2 in Human Epithelial Skin Lesions: A Systematic Review of Immunohistochemical Studies. Appl Immunohistochem Mol Morphol. 2021 Mar 1;29(3):163-174. doi: 10.1097/PAI.0000000000000871.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kush Dhody, MBBS, MS, CCRA study director
Amarex Clinical Research, LLC (Amarex)
Brian Berman, MD, PhD principal investigator
Center for Clinical and Cosmetic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STP705 in people with Bowen's Disease and Cutaneous Squamous Cell Carcinoma in Situ, run by Sirnaomics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT). (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.