Seborrheic KeratosisPhase 2NCT05136144
Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis
A Phase 2 study testing SM-020 in people with Seborrheic Keratosis, run by DermBiont, Inc. at 1 site in El Salvador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seborrheic Keratosis
- What is being tested?
- SM-020
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEl Salvador
- Study dates
- 19 Oct 2021to 31 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to comprehend and willing to sign an informed consent form (ICF).
- At least 18 years of age.
- Must have a minimum of 5 eligible facial, truncal, intertriginous, or extremity SKTLs. A maximum of 10 will be targeted for treatment. There will be a maximum of 5 PLA 2's per subject. An eligible SKTL must each:
- Have one or more of the following clinical features throughout the entirety of the lesion consistent with SKs: stuck-on, warty, waxy, scaly, milia-like cyst, tan to black
- For subjects randomized for assessment with clinical diagnosis and dermoscopy, SKs must also have one or more of the dermoscopy features throughout the entirety of the lesion: moth-eaten border, fingerprinting structures, network-like pattern, network pattern, crypts (comedo-like openings), milia cysts, pinpoint vessels, hairpin vessels, fat fingers, sharp demarcation, blue-white pigmentation, more than one color, cerebriform structure, irregular, polymorphic pattern, fissures, white artefacts, irregular vessels (Simionescu et al., 2012).
- Have a Physician's Lesion Assessment (PLA) of 2 (a thickness that is ≤1mm) or 3 (a thickness that is >1mm)
Show all 16Show fewer
- Have a greatest diameter that is ≥5mm and ≤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.
- As applicable, technical ability and willingness to apply Investigational Product (IP).
- Must be willing to have all partial, incompletely, or non-responding SKTLs removed surgically by shave excision during the final visit.
Who cannot join
- 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.
- 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, or unwilling to meet the following washouts, prior to the Baseline visit:
- Retinoids; 180 days
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- Glucocorticosteroids; 28 days
- Anti-metabolites (e.g., methotrexate); 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
1 site in 1 country.
About this study
Official title: Open-Label Adaptive Design Study to Explore the Safety and Efficacy of Multiple Treatment Regimens With the Akt Inhibitor SM-020 Gel in 1.0% and 0.1% Gel Formulations in Subjects With Seborrheic Keratosis
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.
Read the detailed description
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.
Variables to be considered in the design of cohorts include frequency of application and duration of application.
The maximum duration of a treatment period is 12 weeks for any subject.
35 Subjects have been enrolled to date in the following 7 cohorts:
Cohort 1: SM-020 gel 1.0% BID (Bis in die) for 14 days
Cohort 2: SM-020 gel 1.0% BID for 28 days
Cohort 3: SM-020 gel 1.0% BID pulsed dosing 4 days on/4 days off
Cohort 4: SM-020 gel 1.0% BID for 28 days to facial SKs
Cohort 5: SM-020 gel 1.0% TIW (Three times a week) under occlusion for 28 days
Cohort 6: SM-020 gel 1.0% BID for 28 days with intertriginous SKs
Cohort 7: SM-020 gel 0.1% BID for 28 days to facial SKs
Anticipated subsequent cohorts to be enrolled:
Cohort 8: SM-020 gel 1.0% BID for 56 days
Cohort 9: SM-020 gel 1.0% BID for 28 days
Cohort 10: SM-020 gel 1.0% QD (Quaque die) for 28 days
Cohort 11: SM-020 gel 0.1% BID for 28 days
- Conditions
- Seborrheic Keratosis
- Being tested
- SM-020
- 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-020Drug
Topical Akt Inhibitor SM-020 Gel
| Study group | Role | What they receive |
|---|---|---|
| SM-020 | Experimental | Topical Akt Inhibitor SM-020 Gel Receives: Drug: SM-020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve clearance (PLA score of 0) at final study visit
Measured: Through 20 weeks
Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day QD treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs that achieve clearance (PLA score of 0)
Measured: Through 20 weeks
Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 0.1%
Measured by the proportion of all SKTLs that achieve clearance (PLA score of 0)
Measured: Through 20 weeks
Secondary outcomes (8)
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs that achieve clearance (PLA score of 0)
Measured: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a PLA of 0 or 1
Measured: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of subjects achieving clearance of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Measured: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of subjects achieving clearance of at least 5 of all SKTLs
Measured: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs/subject, facial SKTLs/subject, truncal SKTLs/subject, intertriginous SKTLs/subject, and extremity SKTLs/subject achieving a PLA of 0
Measured: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA (Subject's Self-Assessment) of 0 or 1
Measured: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the proportion of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA of 0
Measured: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Measured by the percent recurrence of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Measured: Through 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start19 Oct 2021
- Primary completion31 May 2024 (estimated)
- Study completion31 Jul 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Adaptive design
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermBiont, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zepeda Dermatologia
- Responsible party
- Sponsor
- Investigators
- David Zepeda, MD, Principal investigator, Zepeda Dermatologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136144
- Sponsor's protocol ID
- DBI-SM-201
- Status last verified
- Sep 2023
- First submitted
- 8 Nov 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Adaptive Design Study to Explore the Safety and Efficacy of Multiple Treatment Regimens With the Akt Inhibitor SM-020 Gel in 1.0% and 0.1% Gel Formulations in Subjects With Seborrheic Keratosis
- ClinicalTrials.gov ID
- NCT05136144
- Acronym / sponsor ID
- DBI-SM-201
- Conditions
- Seborrheic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Zepeda Dermatologia
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 29 Nov 2021 (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.
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.
Detailed description
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.
Variables to be considered in the design of cohorts include frequency of application and duration of application.
The maximum duration of a treatment period is 12 weeks for any subject.
35 Subjects have been enrolled to date in the following 7 cohorts:
Cohort 1: SM-020 gel 1.0% BID (Bis in die) for 14 days
Cohort 2: SM-020 gel 1.0% BID for 28 days
Cohort 3: SM-020 gel 1.0% BID pulsed dosing 4 days on/4 days off
Cohort 4: SM-020 gel 1.0% BID for 28 days to facial SKs
Cohort 5: SM-020 gel 1.0% TIW (Three times a week) under occlusion for 28 days
Cohort 6: SM-020 gel 1.0% BID for 28 days with intertriginous SKs
Cohort 7: SM-020 gel 0.1% BID for 28 days to facial SKs
Anticipated subsequent cohorts to be enrolled:
Cohort 8: SM-020 gel 1.0% BID for 56 days
Cohort 9: SM-020 gel 1.0% BID for 28 days
Cohort 10: SM-020 gel 1.0% QD (Quaque die) for 28 days
Cohort 11: SM-020 gel 0.1% BID for 28 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adaptive design
| Arm | Type | Receives |
|---|---|---|
| SM-020 | Experimental | Drug: SM-020Topical Akt Inhibitor SM-020 Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Must be able to comprehend and willing to sign an informed consent form (ICF).
- At least 18 years of age.
- Must have a minimum of 5 eligible facial, truncal, intertriginous, or extremity SKTLs. A maximum of 10 will be targeted for treatment. There will be a maximum of 5 PLA 2's per subject. An eligible SKTL must each:
- 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.
Key exclusion criteria (23 listed)
- 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.
- 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, or unwilling to meet the following washouts, prior to the Baseline visit:
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-020Topical Akt Inhibitor SM-020 Gel | Drug | SM-020 |
Primary outcome
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Time frame: Through 20 weeks
Measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve clearance (PLA score of 0) at final study visit
Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day QD treatment with SM-020 gel 1.0%
Time frame: Through 20 weeks
Measured by the proportion of all SKTLs that achieve clearance (PLA score of 0)
Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 0.1%
Time frame: Through 20 weeks
Measured by the proportion of all SKTLs that achieve clearance (PLA score of 0)
8 secondary outcomes
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Time frame: Through 20 weeks
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Time frame: Through 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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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.
David Zepeda, MD principal investigator
Zepeda Dermatologia
1 site 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 in people with Seborrheic Keratosis, run by DermBiont, Inc. at 1 site in El Salvador.
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 16 inclusion and 23 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 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0% (time frame: Through 20 weeks). 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 3 Oct 2023.