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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by G&E Herbal Biotechnology Co., LTD
Sponsor:
Information provided by (Responsible Party):
G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier:
NCT01516515
First received: January 17, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

This Phase II study is to evaluate the efficacy of SR-T100 gel at different concentrations (1.0% and 2.3% of SM in Solanum undatum plant extract) in patient with Actinic Keratosis (AK).


Condition Intervention Phase
Actinic Keratosis
Drug: Vehicle gel
Drug: SR-T100 with 1.0% of SM
Drug: SR-T100 with 2.3% of SM
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Dose-ranging Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK)

Resource links provided by NLM:


Further study details as provided by G&E Herbal Biotechnology Co., LTD:

Primary Outcome Measures:
  • Total clearance rate: [ Time Frame: 8-week post-EOT visit (scheduled at Week 24 visit) ] [ Designated as safety issue: No ]
    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) .


Secondary Outcome Measures:
  • Partial clearance rate [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 103
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo, gel
placebo comparator
Drug: Vehicle gel
placebo
Other Name: Vehicle gel
Active Comparator: SR-T100 with 1.0% of SM, gel
1.0% of SM in Solanum undatum plant extract
Drug: SR-T100 with 1.0% of SM
1.0% of SM in Solanum undatum plant extract
Other Name: SR-T100
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 Name: SR-T100

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516515

Contacts
Contact: Kou-Wha Kuo, PhD 886-6-505-2976 ext 201 kwkuo@geherbs.com.tw

Locations
United States, California
Moy-Fincher-Chipps Facial Plastics/Dermatology Cedars Sinai Recruiting
Beverly Hills, California, United States, 90210
Contact: Ronald Moy, MD    919-371-8334    Ron.Moy@TrialConcierge.com   
Principal Investigator: Ronald Moy, MD         
United States, Florida
Palm Beach Research Recruiting
West Palm Beach, Florida, United States, 33409
Contact: John Goodman, MD    561-689-0606    DrGoodman@PalmBeachResearch.com   
Principal Investigator: John Goodman, MD         
United States, Michigan
Grekin Skin Institute Recruiting
Warren, Michigan, United States, 48088
Contact: Steven K Grekin, DO    586-759-5525    sg222@aol.com   
Principal Investigator: Steven K Grekin, DO         
United States, North Carolina
Wake Research Associates Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Adnan Nasir, MD. PhD.    919-781-2514    investigator@wakeresearch.com   
Principal Investigator: Adnan Nasir, MD. PhD.         
United States, Texas
Suzanne Bruce and Associates,P.A. The Center for Skin Research Recruiting
Houston, Texas, United States, 77056
Contact: Suzanne Bruce, MD    713-985-0210    sbruce@sba-skincare.com   
Principal Investigator: Suzanne Bruce, MD         
United States, Washington
Premier Clinical Research Recruiting
Spokane, Washington, United States, 99204
Contact: William P Werschler, MD    509-343-3710    research@premierclinicalresearch.com   
Principal Investigator: William P Werschler, MD         
Sponsors and Collaborators
G&E Herbal Biotechnology Co., LTD
Investigators
Principal Investigator: Adnan Nasir, MD. PhD. Wake Research Associates
  More Information

No publications provided

Responsible Party: G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier: NCT01516515     History of Changes
Other Study ID Numbers: GESRTAKB
Study First Received: January 17, 2012
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by G&E Herbal Biotechnology Co., LTD:
Actinic Keratosis
AK

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014