A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers

NCT06409195 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CT-217
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• Percentage of lesions that achieve a 50% reduction in greatest diameter of cohort-assigned TL(s) at week 6 compared to baseline

  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.

  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.

  Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, and Week 8

Study Arms (5)

Cohort 1

EXPERIMENTAL

Cohort 1: SM-020 gel 1.0% BID for 28 days to superficial BCCs

Drug: SM-020 1% Gel

Cohort 2

EXPERIMENTAL

Cohort 2: SM-020 gel 1.0% BID for 28 days to nodular BCCs

Drug: SM-020 1% Gel

Cohort 3

EXPERIMENTAL

Cohort 3: SM-020 gel 1.0% BID for 28 days to infiltrating BCCs

Drug: SM-020 1% Gel

Cohort 4

EXPERIMENTAL

Cohort 4: SM-020 gel 1.0% BID for 28 days to SCCISs

Drug: SM-020 1% Gel

Cohort 5

EXPERIMENTAL

Cohort 5: SM-020 gel 1.0% BID for 28 days to SKs

Drug: SM-020 1% Gel

Interventions

SM-020 1% Gel DRUG

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.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• DermBiont, Inc.: lead

Study Sites (1)

Dermatology, Laser and Vein Specialist

Charlotte, North Carolina, 28207, United States

RECRUITING

MeSH Terms

Interventions

Gels

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Joanna Jay

CONTACT

510-607-8155; joanna.j@dermbiont.com

Emma Taylor

CONTACT

510-607-8155; emma@dermbiont.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 10, 2024
• Study Start: March 25, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

US (1)