Actively Recruiting
A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
Led by DermBiont, Inc. · Updated on 2024-05-10
60
Participants Needed
4
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of the trial is to evaluate the safety and efficacy of SM-020 gel 1.0% in subjects with Seborrheic Keratosis (SK) compared to vehicle gel. It is a randomized, double-blind, vehicle-controlled trial. Approximately 60 subjects will be enrolled. Subjects will apply their assigned investigational product twice daily for 4 consecutive weeks. Subjects will be followed for 12-weeks post final application for a total of approximately 16-weeks of required participation in the study.
CONDITIONS
Official Title
A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Completed HIPAA authorization for use of health information
- At least 18 years old
- Have 5 to 10 eligible seborrheic keratosis target lesions on face, trunk, skin folds, or limbs
- Lesions must have clinical features consistent with seborrheic keratosis and meet size (greater than 5mm and up to 15mm) and thickness (up to 1mm) criteria
- Lesions must be well-defined, separate, not pedunculated, not on eyelid, and not within 5mm of orbital rim
- Free from diseases or conditions that could impair lesion evaluation or increase risk
- Willing and able to follow study instructions and attend visits
- Agree to have any non-responding lesions surgically removed at study end
You will not qualify if you...
- Positive pregnancy test, pregnant, lactating, or female of childbearing potential not using birth control
- Seborrheic keratosis lesions that are atypical or rapidly growing
- Lesions with features indicating possible malignancy
- Presence of multiple eruptive seborrheic keratosis lesions
- Current systemic cancer
- Recent use of systemic therapies such as retinoids, chemotherapy, immunosuppressants, biologics, steroids, anti-metabolites, vismodegib, photosensitizing drugs within specified washout periods
- Recent use of topical treatments like laser, light therapy, cryotherapy, imiquimod, 5-fluorouracil, retinoids, chemical peels, steroids, or antibiotics near lesions within specified washout periods
- Recent cutaneous malignancy, sunburn, pre-malignant skin conditions, or body art near lesions
- History of sensitivity to study product ingredients
- Current skin diseases or conditions that may interfere with study or increase risk
- 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: 4 locations
1
Driven Research LLC
Coral Gables, Florida, United States, 33134
Actively Recruiting
2
Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112
Actively Recruiting
3
Oregon Medical Research Center
Portland, Oregon, United States, 97201
Actively Recruiting
4
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Actively Recruiting
Research Team
N
Naho Kasukawa
CONTACT
J
Joanna Jay
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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