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

January 17, 2012
March 13, 2014
February 2013
December 2014   (final data collection date for primary outcome measure)
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) .
Same as current
Complete list of historical versions of study NCT01516515 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Phase II Dose-ranging Study of SR-T100 to Treat Actinic Keratosis
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)

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Actinic Keratosis
  • Drug: Vehicle gel
    placebo
    Other Name: Vehicle gel
  • Drug: SR-T100 with 1.0% of SM
    1.0% of SM in Solanum undatum plant extract
    Other Name: SR-T100
  • Drug: SR-T100 with 2.3% of SM
    2.3% of SM in Solanum undatum plant extract
    Other Name: SR-T100
  • Placebo Comparator: placebo, gel
    placebo comparator
    Intervention: Drug: Vehicle gel
  • Active Comparator: SR-T100 with 1.0% of SM, gel
    1.0% of SM in Solanum undatum plant extract
    Intervention: Drug: SR-T100 with 1.0% of SM
  • Active Comparator: SR-T100 with 2.3% of SM, gel
    2.3% of SM in Solanum undatum plant extract
    Intervention: Drug: SR-T100 with 2.3% of SM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
103
March 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Kou-Wha Kuo, PhD 886-6-505-2976 ext 201 kwkuo@geherbs.com.tw
United States
 
NCT01516515
GESRTAKB
No
G&E Herbal Biotechnology Co., LTD
G&E Herbal Biotechnology Co., LTD
Not Provided
Principal Investigator: Adnan Nasir, MD. PhD. Wake Research Associates
G&E Herbal Biotechnology Co., LTD
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP