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Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis

Primary Purpose

Seborrheic Keratosis

Status
Active
Phase
Phase 2
Locations
El Salvador
Study Type
Interventional
Intervention
SM-020
Sponsored by
DermBiont, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrheic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. At least 18 years of age.
  2. Have four eligible SKs on the face, trunk, or extremities. An eligible SK must:

    1. Have a clinically typical appearance
    2. Have a Physician's Lesion Assessment (PLA) of ≥2
    3. Have a length that is ≥ 1mm and ≤ 15mm
    4. Have a width that is ≥ 1mm and ≤ 15mm
    5. Have a thickness that is ≤ 2mm
    6. Be a discrete lesion
    7. Not be covered with hair which, in the Investigator's opinion, would interfere with the study medication treatment or the study evaluations
    8. Not be pedunculated
  3. 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.
  4. Must be willing and able to follow all study instructions and to attend all study visits.
  5. As applicable, technical ability and willingness to apply Investigational Product (IP).
  6. Must be able to comprehend and willing to sign an informed consent form (ICF).

Exclusion Criteria:

  1. 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.
  2. Have SK lesions that are clinically atypical and/or rapidly growing in size.
  3. Presence of multiple eruptive SK lesions (sign of Leser-Trelat)
  4. Current systemic malignancy.
  5. Any use of the following systemic therapies within the specified period prior to the Screening visit:

    1. Retinoids; 180 days
    2. Glucocorticosteroids; 28 days
    3. Anti-metabolites (e.g., methotrexate); 28 days
  6. 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:

    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-flurouracil, or ingenol mebutate; 60 days
    3. Microdermabrasion or superficial chemical peels; 14 days
    4. Glucocorticosteroids or antibiotics; 14 days
  7. 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:

    1. Cutaneous malignancy; 180 days
    2. Sunburn; currently
    3. Excessive suntan; currently
    4. A pre-malignancy (e.g., actinic keratosis); currently
    5. Body art (e.g., tattoos, piercing, etc.); currently
  8. History of sensitivity to any of the ingredients in the study medications.
  9. 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.
  10. 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

Arm Type

Experimental

Arm Label

SM-020

Arm Description

Topical Akt Inhibitor SM-020 Gel

Outcomes

Primary Outcome Measures

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
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)
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)

Secondary Outcome Measures

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)
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
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
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
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
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
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
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

Full Information

First Posted
November 8, 2021
Last Updated
September 29, 2023
Sponsor
DermBiont, Inc.
Collaborators
Zepeda Dermatologia
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1. Study Identification

Unique Protocol Identification Number
NCT05136144
Brief Title
Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DermBiont, Inc.
Collaborators
Zepeda Dermatologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Adaptive design
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SM-020
Arm Type
Experimental
Arm Description
Topical Akt Inhibitor SM-020 Gel
Intervention Type
Drug
Intervention Name(s)
SM-020
Intervention Description
Topical Akt Inhibitor SM-020 Gel
Primary Outcome Measure Information:
Title
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Description
Measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve clearance (PLA score of 0) at final study visit
Time Frame
Through 20 weeks
Title
Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day QD treatment with SM-020 gel 1.0%
Description
Measured by the proportion of all SKTLs that achieve clearance (PLA score of 0)
Time Frame
Through 20 weeks
Title
Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 0.1%
Description
Measured by the proportion of all SKTLs that achieve clearance (PLA score of 0)
Time Frame
Through 20 weeks
Secondary Outcome Measure Information:
Title
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Description
Measured by the proportion of facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs that achieve clearance (PLA score of 0)
Time Frame
Through 20 weeks
Title
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Description
Measured by the proportion of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a PLA of 0 or 1
Time Frame
Through 20 weeks
Title
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Description
Measured by the proportion of subjects achieving clearance of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Time Frame
Through 20 weeks
Title
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Description
Measured by the proportion of subjects achieving clearance of at least 5 of all SKTLs
Time Frame
Through 20 weeks
Title
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Description
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
Time Frame
Through 20 weeks
Title
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Description
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
Time Frame
Through 20 weeks
Title
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Description
Measured by the proportion of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA of 0
Time Frame
Through 20 weeks
Title
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Description
Measured by the percent recurrence of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Time Frame
Through 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) 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. 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. 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Zepeda, MD
Organizational Affiliation
Zepeda Dermatologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zepeda Dermatologia
City
Santa Tecla
State/Province
La Libertad
Country
El Salvador

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis

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