Seborrheic Keratosis Clinical Trial
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.
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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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 | |
| Active, not 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 |
NCT02667288 -
An Open-Label Safety Study of A-101 Solution
|
Phase 3 | |
| Completed |
NCT02667236 -
A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis.
|
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 |