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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01516515
Recruitment Status : Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : February 15, 2018
Information provided by (Responsible Party):
G&E Herbal Biotechnology Co., LTD

Brief Summary:
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 or disease Intervention/treatment Phase
Actinic Keratosis Drug: Vehicle gel Drug: SR-T100 with 2.3% of SM Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
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)
Study Start Date : February 2013
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: placebo, gel
placebo comparator
Drug: Vehicle gel

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

Primary Outcome Measures :
  1. 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 :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01516515

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

Responsible Party: G&E Herbal Biotechnology Co., LTD Identifier: NCT01516515     History of Changes
Other Study ID Numbers: GESRTAKB
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

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

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