Clinical Trials Logo

Clinical 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. Based on the results at any time from the first and subsequent cohorts, additional cohorts will explore different dosing regimens.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05136144
Study type Interventional
Source DermBiont, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 19, 2021
Completion date July 31, 2024

See also
  Status Clinical Trial Phase
Completed NCT04229277 - Fast Track Diagnosis of Skin Cancer by Advanced Imaging N/A
Completed NCT02260180 - Study of A-101 for the Treatment of Seborrheic Keratosis Phase 2
Completed NCT01214564 - Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis Phase 2
Recruiting NCT06108024 - A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis Phase 2
Completed NCT06046144 - Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors
Completed NCT03846531 - Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study N/A
Completed NCT03148691 - A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis Phase 2
Completed NCT03487588 - An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses Phase 4
Completed NCT02160626 - Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis Phase 2
Completed NCT00540566 - Optical Biopsy of Human Skin in Conjunction With Laser Treatment
Completed NCT01159860 - Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses? N/A
Terminated NCT04688749 - Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage
Completed NCT02667275 - A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis Phase 3
Completed NCT02667236 - A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis. Phase 3
Completed NCT02667288 - An Open-Label Safety Study of A-101 Solution Phase 3
Completed NCT05353374 - Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization N/A
Terminated NCT04249115 - Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study N/A