Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis
Study Details
Study Description
Brief Summary
This is a first-in-humans adaptive design open label trial to explore the safety and efficacy of SM-020. Multiple dosing cohorts will be enrolled. The first cohort will have a two-week treatment period of twice daily applications followed by a four-week follow-up period. Based on the results at any time from the first and subsequent cohorts, additional cohorts will explore different dosing regimens.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SM-020 Topical Akt Inhibitor SM-020 Gel |
Drug: SM-020
Topical Akt Inhibitor SM-020 Gel
|
Outcome Measures
Primary Outcome Measures
- Proportion of treated Seborrheic Keratoses (SKs) with at least a 1 grade improvement in PLA score [4 weeks after last dose]
Change from start of the treatment period through 4 weeks safety follow-up
Secondary Outcome Measures
- Proportion of treated SKs with a Physician's Lesion Assessment (PLA) of 0 or 1 [4 weeks after last dose]
Change from start of the treatment period through 4 weeks safety follow-up
- Proportion of treated SKs with a PLA of 0 [4 weeks after last dose]
Change from start of the treatment period through 4 weeks safety follow-up
- Proportion of treated SKs with a PLA of 0 or 1 [At week 12]
Change from start of the treatment period to week 12
- Proportion of treated SKs with a PLA of 0 [At week 12]
Change from start of the treatment period to week 12
- Proportion of treated SKs with a Subject Self Assessment (SSA) of 0 or 1 [4 weeks after last dose]
Change from start of the treatment period through 4 weeks safety follow-up
- Proportion of treated SKs with a SSA of 0 [4 weeks after last dose]
Change from start of the treatment period through 4 weeks safety follow-up
- Proportion of treated SKs with a SSA of 0 or 1 [At week 12]
Change from start of the treatment period to week 12
- Proportion of treated SKs with a SSA of 0 [At week 12]
Change from start of the treatment period to week 12
- Time to treated SKs achieving a PLA of 0 or 1 [At study exit. In this adaptive design trial, study exit will be 4 to 10 weeks after completion of the treatment period.]
Duration of time from Baseline/Day 1 (PLA 3 or 2) to PLA of 0 or 1
- Time to treated SKs achieving a PLA of 0 [At study exit. In this adaptive design trial, study exit will be 4 to 10 weeks after completion of the treatment period.]
Duration of time from Baseline/Day 1 (PLA 3 or 2) to PLA of 0
Eligibility Criteria
Criteria
Inclusion Criteria:
-
At least 18 years of age.
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Have four eligible SKs on the face, trunk, or extremities. An eligible SK must:
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Have a clinically typical appearance
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Have a Physician's Lesion Assessment (PLA) of ≥2
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Have a length that is ≥ 1mm and ≤ 15mm
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Have a width that is ≥ 1mm and ≤ 15mm
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Have a thickness that is ≤ 2mm
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Be a discrete lesion
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Not be covered with hair which, in the Investigator's opinion, would interfere with the study medication treatment or the study evaluations
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Not be pedunculated
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Must be in good general health and free of any known disease state or physical condition which, in the Investigator's opinion, might impair evaluation of any target SK lesion or which exposes the subject to an unacceptable risk by study participation.
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Must be willing and able to follow all study instructions and to attend all study visits.
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As applicable, technical ability and willingness to apply Investigational Product (IP).
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Must be able to comprehend and willing to sign an informed consent form (ICF).
Exclusion Criteria:
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Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study.
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Have SK lesions that are clinically atypical and/or rapidly growing in size.
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Presence of multiple eruptive SK lesions (sign of Leser-Trelat)
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Current systemic malignancy.
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Any use of the following systemic therapies within the specified period prior to the
Screening visit:
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Retinoids; 180 days
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Glucocorticosteroids; 28 days
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Anti-metabolites (e.g., methotrexate); 28 days
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Any use of the following topical therapies within the specified period prior to the Screening visit on, or in a proximity to any target SK lesion, that in the Investigator's opinion could interfere with the study medication treatment or the study assessments:
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Laser, light or other energy-based therapy [e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)]; 180 days
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Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol mebutate; 60 days
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Microdermabrasion or superficial chemical peels; 14 days
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Glucocorticosteroids or antibiotics; 14 days
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Occurrence or presence of any of the following within the specified period prior to the Screening visit on or in the proximity of any target SK lesion that, in the Investigator's opinion, could interfere with the study medication treatment or the study assessments:
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Cutaneous malignancy; 180 days
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Sunburn; currently
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Excessive suntan; currently
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A pre-malignancy (e.g., actinic keratosis); currently
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Body art (e.g., tattoos, piercing, etc.); currently
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History of sensitivity to any of the ingredients in the study medications.
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Any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) 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.
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Participation in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to the Screening visit.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zepeda Dermatologia | Santa Tecla | La Libertad | El Salvador |
Sponsors and Collaborators
- DermBiont, Inc.
- Zepeda Dermatologia
Investigators
- Principal Investigator: David Zepeda, MD, Zepeda Dermatologia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DBI-SM-201