Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis

Study Overview
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Brief Summary
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This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in patient with Actinic Keratosis (AK).

Official Title
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A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK)

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Vehicle gel
* Drug: SR-T100 with 2.3% of SM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female; aged ≥ 18 years old. Patient who accepts to enter the study by signing written informed consent. Patient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic, non-hypertrophic AK, located with or without a contiguous 25cm2 areas. Patient allows biopsy to be performed on selected lesion. Patient agrees to apply the study medication on prescribed treatment area with an occlusive dressing at least 20 hours per day. Patient agrees photographs to be taken on selected lesion and used as part of the study data package. Patient in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG). Sexually active female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study. Exclusion Criteria: Patient with recurrent invasive squamous cell carcinoma (SCC). Patient has grossly suspicious or inflamed lymph nodes on physical examination. Patient has evidence of clinically significant or unstable medical conditions. Patient has any skin condition in the treatment area that may be made worse by treatment. Patient currently uses or had used on the treatment area(s) OTC retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil (5-FU), imiquimod, topical diclofenac, retinoids, or other topical AK treatments (such as laser abrasion, dermabrasion, glycolic acids, or chemical peels) 28 days prior to screening visit. Patient had received systemic cancer chemotherapy or immunosuppressant; on the target evaluation area that psoralen plus UVA therapy, UVB therapy were treated 6 months prior to screening visit. Patient currently uses or has used prednisone and/or prednisolone (≥ 10 mg or the equivalent) more than 2 weeks continuously within 12 weeks prior to randomization visit. Engaging in activities involving excessive or prolonged exposure to sunlight. History of allergy or sensitivity to related compounds or other components of the investigational product formulation. Woman who is pregnant, lactating or planning to become pregnant during the study. Patient used any investigational drug within 8 weeks prior to the screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo, gel<br>placebo comparator | Drug: Vehicle gel<br>* placebo<br>|
| Active Comparator: SR-T100 with 2.3% of SM, gel<br>2.3% of SM in Solanum undatum plant extract | Drug: SR-T100 with 2.3% of SM<br>* 2.3% of SM in Solanum undatum plant extract<br>* Other names: SR-T100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total clearance rate: | The proportion of patients achieving total clearance of AK lesions in the treatment area (in total of 25cm2 area) at 8-week post-EOT visit (scheduled at Week 24 visit) . | 8-week post-EOT visit (scheduled at Week 24 visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial clearance rate | The proportion of patients achieving ≥ 75% total clinically assessed AK lesion counts out of all target lesions in the treatment area (in total of 25cm2 area) at the post-EOT visit (8 weeks after EOT visit). | 24 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AK, Actinic Keratosis