Trial Title:
A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
NCT ID:
NCT06108024
Condition:
Seborrheic Keratosis
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Keratosis, Seborrheic
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
SM-020 gel 1.0%
Description:
SM-020 gel 1.0% will be applied topically. Subjects will be treated with twice daily
application to 5 to 10 SKTLs for approximately 28 days.
Arm group label:
SM-020 gel 1.0%
Intervention type:
Drug
Intervention name:
Vehicle gel
Description:
Vehicle gel will be applied topically. Subjects will be treated with twice daily
application to 5 to 10 SKTLs for approximately 28 days.
Arm group label:
Vehicle gel
Summary:
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.
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. Must have a minimum of 5 eligible facial, truncal, intertriginous, or extremity
SKTLs. A maximum of 10 SKTLs will be targeted for treatment. An eligible SKTL must :
1. Have one or more of the following clinical features throughout the entirety of
the lesion consistent with SKs: stuck-on, sharply demarcated, warty, waxy,
scaly, milia-like cyst, tan to black
2. For subjects randomized for eligibility assessment with dermoscopy, SKs must
also 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, sharp demarcation, blue-white pigmentation/veil as
long as milia and crypts are present within, more than one color, cerebriform
structure (network-like pattern/gyri and sulci/ridges and fissures/fat
fingers), irregular vessels (inframammary only), granularity at periphery,
stalactite/Tsingy pattern, plate-like/fractured pattern (Simionescu et al.,
2012)
3. Have a Physician's Lesion Assessment (PLA) of 2 (a thickness that is ≤1mm)
4. Have a greatest diameter that is >5mm but ≤15mm
5. Be a discrete, well-defined, separate lesion
6. Not be covered with hair which, in the Investigator's opinion, would interfere
with the study gel treatment or the study evaluations
7. Not be pedunculated
8. Not be on the eyelid
9. Not be within 5mm of the orbital rim
5. Must be free of any known disease state or physical condition which, in the
Investigator's opinion, might impair evaluation of any SKTL or which exposes the
subject to an unacceptable risk by study participation.
6. Must be willing and able to follow all study instructions and to attend all study
visits.
7. Must be willing to have all partial, incompletely, or non-responding SKTLs removed
surgically by shave excision during the final 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. SK lesions that 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, for lesions randomized to
dermoscopy, SK lesions must not have a moth-eaten border or fingerprint structures
indicative of lentigos or a network pattern indicative of a melanocytic lesion.
4. Presence of multiple eruptive SK lesions (sign of Leser-Trelat).
5. Current systemic malignancy.
6. Any use of the following systemic therapies within the specified period, or
unwilling to meet the following washouts, prior to the Baseline visit and while on
study:
1. Retinoids; 180 days
2. Chemotherapy; 180 days
3. Immunosuppressive therapy; 28 days
4. Biologics (e.g., interferon, interferon inducers, or immunomodulators); 28 days
5. Glucocorticosteroids; 28 days
6. Anti-metabolites (e.g., methotrexate); 28 days
7. Vismodegib; 180 days
8. Known photosensitizing medications or CYP3A inducers/inhibitors; 28 days
7. Any use of the following topical therapies within the specified period, or unwilling
to meet the following washouts, prior to the Baseline visit and while on study, on
or in a proximity to any SKTL that, in the Investigator's opinion, could interfere
with the investigational product study treatment applications or the study
assessments:
1. Laser, light or other energy-based therapy [e.g., intense pulsed light (IPL),
photo-dynamic therapy (PDT)]; 180 days
2. Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or
ingenol mebutate; 60 days
3. Retinoids; 28 days
4. Microdermabrasion or superficial chemical peels; 14 days
5. Glucocorticosteroids or antibiotics; 14 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 SKTL that, in the Investigator's
opinion, could interfere with the investigational product study treatment
applications or the study assessments:
1. Cutaneous malignancy; 180 days
2. Sunburn; currently
3. A pre-malignancy (e.g., actinic keratosis); currently
4. 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:
Driven Research LLC
Address:
City:
Coral Gables
Zip:
33134
Country:
United States
Status:
Recruiting
Contact:
Last name:
Javier Alonso, MD
Facility:
Name:
Minnesota Clinical Study Center
Address:
City:
New Brighton
Zip:
55112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven Kempers, MD
Facility:
Name:
Oregon Medical Research Center
Address:
City:
Portland
Zip:
97201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benjamin Ehst, MD
Facility:
Name:
Oregon Dermatology and Research Center
Address:
City:
Portland
Zip:
97210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Phoebe Rich, MD
Start date:
November 6, 2023
Completion date:
October 15, 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/NCT06108024
