RECRUITING

A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Open-Label study evaluating safety and efficacy of SM-020 Gel 1.0% in subjects with Seborrheic Keratoses and Non-Melanoma Skin Cancers (i.e. Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ). Subjects will be enrolled into 1 of 5 cohorts. Each cohort will enroll approximately 5-10 subjects with at least 1 eligible lesion to be treated. A maximum of 5 lesions may be enrolled per subject. Treatment for all subjects and all lesions will be twice daily for approximately 28 days. Post treatment, residual lesions may be excised per standard of care for histological evaluation. The duration of the study is estimated to be approximately up to 12 weeks from the beginning of the Screening period until the last subject's last visit.

Official Title

Open-Label Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers (Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ)

Quick Facts

Study Start:2024-03-25

Study Completion:2024-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06409195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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. Histologically confirmed seborrheic keratosis, basal cell skin cancer (superficial, nodular, and/or infiltrating subtype) and/or squamous cell carcinoma in situ from screening biopsies 5. At least 1 and up to 5 screened and histologically confirmed eligible NMSC and/or SK lesions max between 0.5-2.0 cm in greatest tumor diameter 6. NMSCs must also meet the following criteria: 7. SKs must also meet the following criteria 8. Must be free of any known disease state or physical condition which, in the Investigator's opinion, might impair evaluation of any treated lesion or which exposes the subject to an unacceptable risk by study participation. 9. Must be willing and able to follow all study instructions and to attend all study visits. 10. Technical ability to apply treatment to all enrolled lesion 11. Must be willing to have all lesions removed surgically by either Mohs micrographic surgery or standard excision for NMSCs or shave excision for SKs at the final 2-week follow up visit.	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. Presence of multiple eruptive SK lesions (sign of Leser-Trelat) 4. Current systemic malignancy. 5. Past history of lymphoproliferative disorder 6. Any use of the following systemic therapies within the specified period prior to the Baseline visit and while on study: 7. Any use of the following topical therapies within the specified period prior to the Baseline visit and while on study on or in a close proximity to any treated lesion (TL) that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments: 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 TL that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments: 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.

Inclusion Criteria

Exclusion Criteria

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. Histologically confirmed seborrheic keratosis, basal cell skin cancer (superficial, nodular, and/or infiltrating subtype) and/or squamous cell carcinoma in situ from screening biopsies
5. At least 1 and up to 5 screened and histologically confirmed eligible NMSC and/or SK lesions max between 0.5-2.0 cm in greatest tumor diameter
6. NMSCs must also meet the following criteria:
7. SKs must also meet the following criteria
8. Must be free of any known disease state or physical condition which, in the Investigator's opinion, might impair evaluation of any treated lesion or which exposes the subject to an unacceptable risk by study participation.
9. Must be willing and able to follow all study instructions and to attend all study visits.
10. Technical ability to apply treatment to all enrolled lesion
11. Must be willing to have all lesions removed surgically by either Mohs micrographic surgery or standard excision for NMSCs or shave excision for SKs at the final 2-week follow up visit.

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. Presence of multiple eruptive SK lesions (sign of Leser-Trelat)
4. Current systemic malignancy.
5. Past history of lymphoproliferative disorder
6. Any use of the following systemic therapies within the specified period prior to the Baseline visit and while on study:
7. Any use of the following topical therapies within the specified period prior to the Baseline visit and while on study on or in a close proximity to any treated lesion (TL) that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments:
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 TL that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments:
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.

Contacts and Locations

Study Contact

Joanna Jay

CONTACT

510-607-8155

joanna.j@dermbiont.com

Emma Taylor

CONTACT

510-607-8155

emma@dermbiont.com

Study Locations (Sites)

Dermatology, Laser and Vein Specialist

Charlotte, North Carolina, 28207

United States

Collaborators and Investigators

Sponsor: DermBiont, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-25

Study Completion Date2024-11

Study Record Updates

Study Start Date2024-03-25

Study Completion Date2024-11

Terms related to this study

Additional Relevant MeSH Terms

Non-Melanoma Skin Cancers