Actively Recruiting
A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers
Led by DermBiont, Inc. · Updated on 2024-05-10
50
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Completed HIPAA authorization to use health information
- At least 18 years old
- Histologically confirmed seborrheic keratosis, basal cell carcinoma (superficial, nodular, or infiltrating), or squamous cell carcinoma in situ from screening biopsies
- Have 1 to 5 eligible lesions confirmed by biopsy, each between 0.5 and 2.0 cm in diameter
- Non-melanoma skin cancers must be primary tumors, located on scalp, face (excluding ears and nose), trunk, or extremities (excluding hands and feet), and suitable for surgical excision or Mohs surgery
- Non-melanoma skin cancers must not be on eyelid or within 5 mm of orbital rim
- Seborrheic keratosis lesions must be less than 1 mm thick, show specified dermoscopy features, be located on scalp, face (including ears), trunk, intertriginous areas, or extremities, and not be on eyelid or within 5 mm of orbital rim
- Free from diseases or conditions that could interfere with lesion evaluation or increase risk
- Willing and able to follow study instructions and attend visits
- Able to apply treatment to all enrolled lesions
- Willing to have lesions surgically removed at final follow-up visit
You will not qualify if you...
- Positive pregnancy test, pregnant, lactating, or female of childbearing potential not using birth control
- Atypical, rapidly growing seborrheic keratosis lesions
- Multiple eruptive seborrheic keratoses (Leser-Trelat sign)
- Current systemic cancer
- Past lymphoproliferative disorder
- Use of systemic retinoids or chemotherapy within 180 days
- Use of immunosuppressives, biologics, glucocorticosteroids, anti-metabolites, or photosensitizing medications within specified timeframes before baseline and during the study
- Use of certain topical therapies near treated lesions within specified timeframes
- Recent cutaneous malignancy near treated lesions (except those enrolled), current sunburn, or body art near lesions
- Sensitivity to ingredients in the study drug
- Current skin diseases or conditions that increase risk or interfere with study
- Participation in another investigational drug trial within 30 days
- History of hypertrophic scarring or keloid formation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dermatology, Laser and Vein Specialist
Charlotte, North Carolina, United States, 28207
Actively Recruiting
Research Team
J
Joanna Jay
CONTACT
E
Emma Taylor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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