Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis
Seborrheic Keratosis
About this trial
This is an interventional treatment trial for Seborrheic Keratosis
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age.
Have four eligible SKs on the face, trunk, or extremities. An eligible SK must:
- Have a clinically typical appearance
- Have a Physician's Lesion Assessment (PLA) of ≥2
- Have a length that is ≥ 1mm and ≤ 15mm
- Have a width that is ≥ 1mm and ≤ 15mm
- Have a thickness that is ≤ 2mm
- Be a discrete lesion
- Not be covered with hair which, in the Investigator's opinion, would interfere with the study medication treatment or the study evaluations
- Not be pedunculated
- 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.
- Must be willing and able to follow all study instructions and to attend all study visits.
- As applicable, technical ability and willingness to apply Investigational Product (IP).
- Must be able to comprehend and willing to sign an informed consent form (ICF).
Exclusion Criteria:
- 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.
- Have SK lesions that are clinically atypical and/or rapidly growing in size.
- Presence of multiple eruptive SK lesions (sign of Leser-Trelat)
- Current systemic malignancy.
Any use of the following systemic therapies within the specified period prior to the Screening visit:
- Retinoids; 180 days
- Glucocorticosteroids; 28 days
- Anti-metabolites (e.g., methotrexate); 28 days
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:
- Laser, light or other energy-based therapy [e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)]; 180 days
- Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol mebutate; 60 days
- Microdermabrasion or superficial chemical peels; 14 days
- Glucocorticosteroids or antibiotics; 14 days
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:
- Cutaneous malignancy; 180 days
- Sunburn; currently
- Excessive suntan; currently
- A pre-malignancy (e.g., actinic keratosis); currently
- Body art (e.g., tattoos, piercing, etc.); currently
- History of sensitivity to any of the ingredients in the study medications.
- 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.
- Participation in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to the Screening visit.
Sites / Locations
- Zepeda Dermatologia
Arms of the Study
Arm 1
Experimental
SM-020
Topical Akt Inhibitor SM-020 Gel