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

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)

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).

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Vehicle gel; Drug: SR-T100 with 2.3% of SM

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Rancho Mirage, California, United States, 92270
      • Contour Dermatology & Cosmetic Surgery Center
  • Colorado
    • Longmont, Colorado, United States, 80501
      • IMMUNOe International Research Centers
  • Florida
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
    • West Palm Beach, Florida, United States, 33406
      • Atlantic Clinical Research Collaborative
  • Texas
    • Katy, Texas, United States, 77056
      • Suzanne Bruce and Associates,P.A. The Center for Skin Research
    • Pflugerville, Texas, United States, 78660
      • Pflugerville Dermatology Clinical Research
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education & Research Foundation, Inc
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female; aged ≥ 18 years old.
2. Patient who accepts to enter the study by signing written informed consent.
3. Patient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic, non-hypertrophic AK, located with or without a contiguous 25cm2 areas.
4. Patient allows biopsy to be performed on selected lesion.
5. Patient agrees to apply the study medication on prescribed treatment area with an occlusive dressing at least 20 hours per day.
6. Patient agrees photographs to be taken on selected lesion and used as part of the study data package.
7. Patient in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).
8. Sexually active female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.

Exclusion Criteria:

1. Patient with recurrent invasive squamous cell carcinoma (SCC).
2. Patient has grossly suspicious or inflamed lymph nodes on physical examination.
3. Patient has evidence of clinically significant or unstable medical conditions.
4. Patient has any skin condition in the treatment area that may be made worse by treatment.
5. 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.
6. 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.
7. 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.
8. Engaging in activities involving excessive or prolonged exposure to sunlight.
9. History of allergy or sensitivity to related compounds or other components of the investigational product formulation.
10. Woman who is pregnant, lactating or planning to become pregnant during the study.
11. Patient used any investigational drug within 8 weeks prior to the screening visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo, gel; placebo comparator	Drug: Vehicle gel; placebo
ACTIVE_COMPARATOR: SR-T100 with 2.3% of SM, gel; 2.3% of SM in Solanum undatum plant extract	Drug: SR-T100 with 2.3% of SM; 2.3% of SM in Solanum undatum plant extract; Other Names: SR-T100

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: G&E Herbal Biotechnology Co., LTD

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (ESTIMATE): January 25, 2012

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Actinic Keratosis; AK
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: GESRTAKB