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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier:
NCT01516515
First received: January 17, 2012
Last updated: June 1, 2017
Last verified: June 2017
  Purpose
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).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)

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) ]
    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 ]
    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: 86
Study Start Date: February 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: SR-T100

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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: June 1, 2017

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 20, 2017