Non-Melanoma Skin CancersPhase 2NCT06409195
A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers
A Phase 2 study testing SM-020 1% Gel in people with Non-Melanoma Skin Cancers, run by DermBiont, Inc. at 1 site in United States.
Trial summary
Open-Label study evaluating safety and efficacy of SM-020 Gel 1.0% in subjects with Seborrheic Keratoses and Non-Melanoma Skin Cancers (i.e. Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ). Subjects will be enrolled into 1 of 5 cohorts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Melanoma Skin Cancers
- What is being tested?
- SM-020 1% Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2024to Nov 2024
- Phase
- Phase 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
- Subjects must meet all of the following criteria to be included in the study:
- Must be able to comprehend and willing to sign an informed consent form (ICF).
- Must complete a signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of the subject's individually identifiable health information.
- Must be at least 18 years of age.
- Histologically confirmed seborrheic keratosis, basal cell skin cancer (superficial, nodular, and/or infiltrating subtype) and/or squamous cell carcinoma in situ from screening biopsies
- At least 1 and up to 5 screened and histologically confirmed eligible NMSC and/or SK lesions max between 0.5-2.0 cm in greatest tumor diameter
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- NMSCs must also meet the following criteria:
- Primary tumor (no recurrent or previously treated tumors)
- Located on the scalp, face (excluding ears and nose), trunk, or extremities (excluding the hands and feet)
- Qualifies for standard surgical excision or Mohs micrographic surgery as primary therapy
- Not be on the eyelid or within 5 mm of the orbital rim
- SKs must also meet the following criteria
- PLA 2 (<1 mm in thickness)
- Have one or more of the following dermoscopy features throughout the entirety of the lesion: crypts (comedo-like openings), milia cysts, hairpin vessels with white halo, fat sharp demarcation, blue-white pigmentation/veil as long as milia and crypts are present within, more than one color, cerebriform structure (gyri and sulci/network-like pattern/ridges and fissures/fat fingers), irregular vessels (inframammary only), granularity at periphery, stalactite/Tsingy pattern, plate-like/fractured pattern (Simionescu et al., 2012) (Note: SK lesions must NOT have any of the following features indicative of malignancy under dermoscopy: pinpoint vessels, smooth blue-white pigmentation/veil without milia or crypts within, hairpin vessels without white halo, white artifacts, irregular vessels (except for inframammary lesions). Additionally, SK lesions must not have a moth-eaten border or fingerprint structures indicative of lentigos or a network pattern indicative of a melanocytic lesion)
- Located on the scalp, face (including ears), trunk, intertriginous areas, or extremities
- Not be on the eyelid or within 5 mm of the orbital rim
- Must be free of any known disease state or physical condition which, in the Investigator's opinion, might impair evaluation of any treated lesion or which exposes the subject to an unacceptable risk by study participation.
- Must be willing and able to follow all study instructions and to attend all study visits.
- Technical ability to apply treatment to all enrolled lesion
- Must be willing to have all lesions removed surgically by either Mohs micrographic surgery or standard excision for NMSCs or shave excision for SKs at the final 2-week follow up visit.
Who cannot join
- Subjects meeting any of the following criterion will be ineligible and excluded from this study:
- Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control (such as oral contraceptive pills (OCPs), Intrauterine devices (IUDs), birth control implants, vaginal rings, or injections) for the duration of the study.
- SK lesions that are clinically atypical and/or rapidly growing in size or number.
- Presence of multiple eruptive SK lesions (sign of Leser-Trelat)
- Current systemic malignancy.
- Past history of lymphoproliferative disorder
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- Any use of the following systemic therapies within the specified period prior to the Baseline visit and while on study:
- Retinoids; 180 days
- Chemotherapy; 180 days
- Immunosuppressive therapy; 28 days
- Biologics (e.g., interferon, interferon inducers, or immunomodulators such as such as Tumor necrosis factor (TNF) inhibitors; Interleukin (IL) inhibitors; B-cells inhibitors; and T-cells inhibitors and other immunomodulatory systemic biologics such as Anti-TNF biologics including: adalimumab (Humira®), certolizumab pegol (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®) and infliximab (Remicade®), and Non-TNF biologics including: abatacept (Orencia®), anakinra (Kineret®), rituximab (Rituxan®), tolcilizumab (Actemra®), tofacitinib (Xeljanz®), and ustekinumab (Stelara®)); 28 days
- Glucocorticosteroids (Oral and intramuscular); 28 days
- Anti-metabolites (e.g., methotrexate); 28 days
- Vismodegib; 180 days
- Subjects taking known photosensitizing medications or CYP3A inhibitors (see Section 6.10 for more details); 28 days
- Any use of the following topical therapies within the specified period prior to the Baseline visit and while on study on or in a close proximity to any treated lesion (TL) that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments:
- Laser, light or other energy-based therapy [e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)]; 180 days
- Liquid nitrogen, electrodessication, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 180 days
- Retinoids; 28 days
- Microdermabrasion or superficial chemical peels; 28 days
- Glucocorticosteroids or antibiotics; 28 days
- Occurrence or presence of any of the following within the specified period prior to the Baseline visit on or in the proximity of any TL that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments:
- Cutaneous malignancy: 180 days (excluding those to be enrolled)
- Sunburn; currently
- Body art (e.g., tattoos, piercing, etc.); currently
- History of sensitivity to any of the ingredients in the investigational product.
- Any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or other condition(s) (e.g., sunburn, excessive hair, open wounds, lupus, photosensitive disorders etc.) that, in the opinion of the Investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
- Participation in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to the Screening visit.
- History of hypertrophic scarring or keloid formation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dermatology, Laser and Vein Specialist
Charlotte, North Carolina, 28207
Razia Ludia
About this study
Official title: Open-Label Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers (Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ)
Open-Label study evaluating safety and efficacy of SM-020 Gel 1.0% in subjects with Seborrheic Keratoses and Non-Melanoma Skin Cancers (i.e. Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ). Subjects will be enrolled into 1 of 5 cohorts. Each cohort will enroll approximately 5-10 subjects with at least 1 eligible lesion to be treated. A maximum of 5 lesions may be enrolled per subject. Treatment for all subjects and all lesions will be twice daily for approximately 28 days. Post treatment, residual lesions may be excised per standard of care for histological evaluation. The duration of the study is estimated to be approximately up to 12 weeks from the beginning of the Screening period until the last subject's last visit.
- Conditions
- Non-Melanoma Skin Cancers
- Being tested
- SM-020 1% Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-020 1% GelDrug
SM-020 gel 1.0% will be applied topically. Subjects will be treated with twice daily application to at least 1 and up to 5 Target Lesions (TLs) for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1: SM-020 gel 1.0% BID for 28 days to superficial BCCs Receives: Drug: SM-020 1% Gel |
| Cohort 2 | Experimental | Cohort 2: SM-020 gel 1.0% BID for 28 days to nodular BCCs Receives: Drug: SM-020 1% Gel |
| Cohort 3 | Experimental | Cohort 3: SM-020 gel 1.0% BID for 28 days to infiltrating BCCs Receives: Drug: SM-020 1% Gel |
| Cohort 4 | Experimental | Cohort 4: SM-020 gel 1.0% BID for 28 days to SCCISs Receives: Drug: SM-020 1% Gel |
| Cohort 5 | Experimental | Cohort 5: SM-020 gel 1.0% BID for 28 days to SKs Receives: Drug: SM-020 1% Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of lesions that achieve a 50% reduction in greatest diameter of cohort-assigned TL(s) at week 6 compared to baseline
Measured: At week 6
Safety and Tolerability will be evaluated through assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs)
Application Site Reactions will be evaluated based on the severity of the signs and symptoms of pain, burning, stinging, pruritus, erythema, edema, exudation, erosion/ulceration, hyperpigmentation,and hypopigmentation.
Measured: Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, and Week 8
Safety and Tolerability as evaluated by review of adverse events
Grade 1 = Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 = Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL Grade 4 = Life-threatening consequences: urgent intervention indicated Grade 5 = Death related to AE with Grade 1 being the minimum value and Grade 5 being the maximum value, with a higher value indicating higher severity.
Measured: Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start25 Mar 2024
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Melanoma Skin CancersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermBiont, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409195
- Sponsor's protocol ID
- CT-217
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers (Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ)
- ClinicalTrials.gov ID
- NCT06409195
- Acronym / sponsor ID
- CT-217
- Conditions
- Non-Melanoma Skin Cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 10 May 2024 (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.
Open-Label study evaluating safety and efficacy of SM-020 Gel 1.0% in subjects with Seborrheic Keratoses and Non-Melanoma Skin Cancers (i.e. Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ). Subjects will be enrolled into 1 of 5 cohorts. Each cohort will enroll approximately 5-10 subjects with at least 1 eligible lesion to be treated. A maximum of 5 lesions may be enrolled per subject. Treatment for all subjects and all lesions will be twice daily for approximately 28 days. Post treatment, residual lesions may be excised per standard of care for histological evaluation. The duration of the study is estimated to be approximately up to 12 weeks from the beginning of the Screening period until the last subject's last visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SM-020 1% GelCohort 1: SM-020 gel 1.0% BID for 28 days to superficial BCCs |
| Cohort 2 | Experimental | Drug: SM-020 1% GelCohort 2: SM-020 gel 1.0% BID for 28 days to nodular BCCs |
| Cohort 3 | Experimental | Drug: SM-020 1% GelCohort 3: SM-020 gel 1.0% BID for 28 days to infiltrating BCCs |
| Cohort 4 | Experimental | Drug: SM-020 1% GelCohort 4: SM-020 gel 1.0% BID for 28 days to SCCISs |
| Cohort 5 | Experimental | Drug: SM-020 1% GelCohort 5: SM-020 gel 1.0% BID for 28 days to SKs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Must be able to comprehend and willing to sign an informed consent form (ICF).
- Must complete a signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of the subject's individually identifiable health information.
- Must be at least 18 years of age.
- Histologically confirmed seborrheic keratosis, basal cell skin cancer (superficial, nodular, and/or infiltrating subtype) and/or squamous cell carcinoma in situ from screening biopsies
- At least 1 and up to 5 screened and histologically confirmed eligible NMSC and/or SK lesions max between 0.5-2.0 cm in greatest tumor diameter
Key exclusion criteria (29 listed)
- Subjects meeting any of the following criterion will be ineligible and excluded from this study:
- Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control (such as oral contraceptive pills (OCPs), Intrauterine devices (IUDs), birth control implants, vaginal rings, or injections) for the duration of the study.
- SK lesions that are clinically atypical and/or rapidly growing in size or number.
- Presence of multiple eruptive SK lesions (sign of Leser-Trelat)
- Current systemic malignancy.
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 |
|---|---|---|
| SM-020 1% GelSM-020 gel 1.0% will be applied topically. Subjects will be treated with twice daily application to at least 1 and up to 5 Target Lesions (TLs) for 28 days. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Percentage of lesions that achieve a 50% reduction in greatest diameter of cohort-assigned TL(s) at week 6 compared to baseline
Time frame: At week 6
Safety and Tolerability will be evaluated through assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs)
Time frame: Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, and Week 8
Application Site Reactions will be evaluated based on the severity of the signs and symptoms of pain, burning, stinging, pruritus, erythema, edema, exudation, erosion/ulceration, hyperpigmentation,and hypopigmentation.
Safety and Tolerability as evaluated by review of adverse events
Time frame: Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, and Week 8
Grade 1 = Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 = Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL Grade 4 = Life-threatening consequences: urgent intervention indicated Grade 5 = Death related to AE with Grade 1 being the minimum value and Grade 5 being the maximum value, with a higher value indicating higher severity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SM-020 1% Gel in people with Non-Melanoma Skin Cancers, run by DermBiont, Inc. 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 20 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanna Jay (510-607-8155, joanna.j@dermbiont.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of lesions that achieve a 50% reduction in greatest diameter of cohort-assigned TL(s) at week 6 compared to baseline (time frame: At week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2024.