Trial Title:
A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers
NCT ID:
NCT06409195
Condition:
Non-Melanoma Skin Cancers
Conditions: Official terms:
Skin Neoplasms
Keratosis
Keratosis, Seborrheic
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SM-020 1% Gel
Description:
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.
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Arm group label:
Cohort 4
Arm group label:
Cohort 5
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Subjects must meet all of the following criteria to be included in the study:
1. Must be able to comprehend and willing to sign an informed consent form (ICF).
2. 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.
3. Must be at least 18 years of age.
4. Histologically confirmed seborrheic keratosis, basal cell skin cancer (superficial,
nodular, and/or infiltrating subtype) and/or squamous cell carcinoma in situ from
screening biopsies
5. 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
6. 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
7. 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
8. 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.
9. Must be willing and able to follow all study instructions and to attend all study
visits.
10. Technical ability to apply treatment to all enrolled lesion
11. 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.
Exclusion Criteria:
Subjects meeting any of the following criterion will be ineligible and excluded from this
study:
1. 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.
2. SK lesions that are clinically atypical and/or rapidly growing in size or number.
3. Presence of multiple eruptive SK lesions (sign of Leser-Trelat)
4. Current systemic malignancy.
5. Past history of lymphoproliferative disorder
6. 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
7. 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
8. 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
9. History of sensitivity to any of the ingredients in the investigational product.
10. 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.
11. Participation in an investigational drug trial in which administration of an
investigational study medication occurred within 30 days prior to the Screening
visit.
12. History of hypertrophic scarring or keloid formation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dermatology, Laser and Vein Specialist
Address:
City:
Charlotte
Zip:
28207
Country:
United States
Status:
Recruiting
Contact:
Last name:
Razia Ludia
Start date:
March 25, 2024
Completion date:
November 2024
Lead sponsor:
Agency:
DermBiont, Inc.
Agency class:
Industry
Source:
DermBiont, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06409195
