Seborrheic KeratosisPhase 2NCT06108024
A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
A Phase 2 study testing SM-020 gel 1.0% in people with Seborrheic Keratosis, run by DermBiont, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seborrheic Keratosis
- What is being tested?
- SM-020 gel 1.0%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Nov 2023to 15 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in the study:
- Must be able to comprehend and willing to sign an informed consent form (ICF).
- 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.
- Must be at least 18 years of age.
- 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 :
- 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
Show all 17Show fewer
- 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)
- Have a Physician's Lesion Assessment (PLA) of 2 (a thickness that is ≤1mm)
- Have a greatest diameter that is >5mm but ≤15mm
- Be a discrete, well-defined, separate lesion
- Not be covered with hair which, in the Investigator's opinion, would interfere with the study gel treatment or the study evaluations
- Not be pedunculated
- Not be on the eyelid
- Not be within 5mm of the orbital rim
- 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.
- Must be willing and able to follow all study instructions and to attend all study visits.
- Must be willing to have all partial, incompletely, or non-responding SKTLs removed surgically by shave excision during the final visit.
Who cannot join
- Subjects meeting any of the following criterion will be ineligible and excluded from this study:
- 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.
- SK lesions that are clinically atypical and/or rapidly growing in size or number.
- 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.
- Presence of multiple eruptive SK lesions (sign of Leser-Trelat).
- Current systemic malignancy.
Show all 30Show fewer
- 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:
- Retinoids; 180 days
- Chemotherapy; 180 days
- Immunosuppressive therapy; 28 days
- Biologics (e.g., interferon, interferon inducers, or immunomodulators); 28 days
- Glucocorticosteroids; 28 days
- Anti-metabolites (e.g., methotrexate); 28 days
- Vismodegib; 180 days
- Known photosensitizing medications or CYP3A inducers/inhibitors; 28 days
- 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:
- 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-fluorouracil, or ingenol mebutate; 60 days
- Retinoids; 28 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 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:
- Cutaneous malignancy; 180 days
- Sunburn; 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 investigational product.
- 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.
- Participation in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to the Screening visit.
- History of hypertrophic scarring or keloid formation.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Driven Research LLC
Coral Gables, Florida, 33134
Javier Alonso, MD
- Recruiting
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Steven Kempers, MD
- Recruiting
Oregon Medical Research Center
Portland, Oregon, 97201
Benjamin Ehst, MD
- Recruiting
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Phoebe Rich, MD
About this study
Official title: Randomized Double-Blind Vehicle-Controlled Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
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
- Seborrheic Keratosis
- Being tested
- SM-020 gel 1.0%, Vehicle gel
- Medical subject headings
- Keratosis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-020 gel 1.0%Drug
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.
Vehicle gelDrug
Vehicle gel will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days.
| Study group | Role | What they receive |
|---|---|---|
| SM-020 gel 1.0% | Active comparator | 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. Receives: Drug: SM-020 gel 1.0% |
| Vehicle gel | Placebo comparator | Vehicle gel will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days. Receives: Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of active over vehicle as measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve a PLA score of 0
The PLA is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The PLA will be determined for each SKTL at all clinic study visits from Visit 1/Screening to Visit 9/Last Visit.
Physician's Lesion Assessment Grade Descriptor
0 Clear: no visible seborrheic keratosis lesion
- Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated)
- Thin: a visible seborrheic keratosis lesion (thickness ≤1mm)
- Thick: a visible seborrheic keratosis lesion (thickness >1mm)
Measured: Screening, Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, and Week 16
Safety and Tolerability as evaluated by assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs) of Seborrheic Keratosis
Application site reactions will be evaluated based on the scores for erythema, edema, exudation, erosion/ulceration, hyperpigmentation, and hypopigmentation by the Investigator, and the additional symptoms of pain, burning, stinging, and pruritus. Scale 0=None, 1=slight, 2=Moderate, 3=Significant with 0 being the minimum value and 3 being the maximum value, with a higher value indicating higher severity.
Measured: Through week 16 (Visit 9)
Safety and Tolerability as evaluated by review of adverse events
Grade 1 = Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 = Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL Grade 4 = Life-threatening consequences: urgent intervention indicated Grade 5 = Death related to AE with Grade 1 being the minimum value and Grade 5 being the maximum value, with a higher value indicating higher severity.
Measured: Through week 16 (Visit 9)
Secondary outcomes (9)
Superiority of active over vehicle as measured by the percentage of facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs that achieve clearance (PLA score of 0)
The Physician's Lesion Assessment (PLA) is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Measured: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a PLA of 0 or 1
The Physician's Lesion Assessment (PLA) is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Measured: Through week 16
Superiority of active over vehicle, based on the time to all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs achieving a PLA of 0
The Physician's Lesion Assessment (PLA) is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Measured: Through week 16
Superiority of active over vehicle as measured by the percentage of subjects achieving clearance of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Measured: Through week 16
Superiority of active over vehicle as measured by the percentage of subjects achieving clearance of at least 60% of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLS, and extremity SKTLs
Measured: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs/subject, facial SKTLs/subject, truncal SKTLs/subject, intertriginous SKTLs/subject, and extremity SKTLs/subject achieving a PLA of 0
The Physician's Lesion Assessment (PLA) is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Measured: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA (Subject's Self-Assessment) of 0 or 1
The SSA is a subject's self-reported assessment of SK lesion severity based on presence of SK and the thickness and coloration of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Measured: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA of 0
The SSA is a subject's self-reported assessment of SK lesion severity based on presence of SK and the thickness and coloration of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Measured: Through week 16
Superiority of active over vehicle as measured by the percent recurrence of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
The SSA is a subject's self-reported assessment of SK lesion severity based on presence of SK and the thickness and coloration of the SK lesion. The minimum value is 0 and the maximum value is 3 with a higher value indicating higher severity or significance.
Measured: Through week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start6 Nov 2023
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermBiont, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108024
- Sponsor's protocol ID
- CT-213
- Status last verified
- May 2024
- First submitted
- 19 Oct 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Vehicle-Controlled Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
- ClinicalTrials.gov ID
- NCT06108024
- Acronym / sponsor ID
- CT-213
- Conditions
- Seborrheic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SM-020 gel 1.0% | Active comparator | Drug: SM-020 gel 1.0%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. |
| Vehicle gel | Placebo comparator | Drug: Vehicle gelVehicle gel will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Must be able to comprehend and willing to sign an informed consent form (ICF).
- 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.
- Must be at least 18 years of age.
- 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 :
- 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.
Key exclusion criteria (30 listed)
- Subjects meeting any of the following criterion will be ineligible and excluded from this study:
- 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.
- SK lesions that are clinically atypical and/or rapidly growing in size or number.
- 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.
- Presence of multiple eruptive SK lesions (sign of Leser-Trelat).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SM-020 gel 1.0%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. | Drug | SM-020 gel 1.0% |
| Vehicle gelVehicle gel will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days. | Drug | Vehicle gel |
Primary outcome
Superiority of active over vehicle as measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve a PLA score of 0
Time frame: Screening, Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, and Week 16
The PLA is an Investigator assessment of SK lesion severity based on presence of SK and the thickness of the SK lesion. The PLA will be determined for each SKTL at all clinic study visits from Visit 1/Screening to Visit 9/Last Visit. Physician's Lesion Assessment Grade Descriptor 0 Clear: no visible seborrheic keratosis lesion 1. Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated) 2. Thin: a visible seborrheic keratosis lesion (thickness ≤1mm) 3. Thick: a visible seborrheic keratosis lesion (thickness >1mm)
Safety and Tolerability as evaluated by assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs) of Seborrheic Keratosis
Time frame: Through week 16 (Visit 9)
Application site reactions will be evaluated based on the scores for erythema, edema, exudation, erosion/ulceration, hyperpigmentation, and hypopigmentation by the Investigator, and the additional symptoms of pain, burning, stinging, and pruritus. Scale 0=None, 1=slight, 2=Moderate, 3=Significant with 0 being the minimum value and 3 being the maximum value, with a higher value indicating higher severity.
Safety and Tolerability as evaluated by review of adverse events
Time frame: Through week 16 (Visit 9)
Grade 1 = Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL Grade 3 = Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL Grade 4 = Life-threatening consequences: urgent intervention indicated Grade 5 = Death related to AE with Grade 1 being the minimum value and Grade 5 being the maximum value, with a higher value indicating higher severity.
9 secondary outcomes
Superiority of active over vehicle as measured by the percentage of facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs that achieve clearance (PLA score of 0)
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a PLA of 0 or 1
Time frame: Through week 16
Superiority of active over vehicle, based on the time to all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs achieving a PLA of 0
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of subjects achieving clearance of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of subjects achieving clearance of at least 60% of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLS, and extremity SKTLs
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs/subject, facial SKTLs/subject, truncal SKTLs/subject, intertriginous SKTLs/subject, and extremity SKTLs/subject achieving a PLA of 0
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA (Subject's Self-Assessment) of 0 or 1
Time frame: Through week 16
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA of 0
Time frame: Through week 16
Superiority of active over vehicle as measured by the percent recurrence of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Time frame: Through week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SM-020 gel 1.0% in people with Seborrheic Keratosis, run by DermBiont, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naho Kasukawa (510-607-8155, naho@dermbiont.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of active over vehicle as measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve a PLA score of 0 (time frame: Screening, Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, and Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.