Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis
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ClinicalTrials.gov Identifier: NCT01516515 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 25, 2012
Last Update Posted
: February 15, 2018
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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 |
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 Name: SR-T100
|
- 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) .
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female; aged ≥ 18 years old.
- Patient who accepts to enter the study by signing written informed consent.
- Patient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic, non-hypertrophic AK, located with or without a contiguous 25cm2 areas.
- Patient allows biopsy to be performed on selected lesion.
- Patient agrees to apply the study medication on prescribed treatment area with an occlusive dressing at least 20 hours per day.
- Patient agrees photographs to be taken on selected lesion and used as part of the study data package.
- Patient in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).
- Sexually active female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.
Exclusion Criteria:
- Patient with recurrent invasive squamous cell carcinoma (SCC).
- Patient has grossly suspicious or inflamed lymph nodes on physical examination.
- Patient has evidence of clinically significant or unstable medical conditions.
- Patient has any skin condition in the treatment area that may be made worse by treatment.
- 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.
- 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.
- 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.
- Engaging in activities involving excessive or prolonged exposure to sunlight.
- History of allergy or sensitivity to related compounds or other components of the investigational product formulation.
- Woman who is pregnant, lactating or planning to become pregnant during the study.
- Patient used any investigational drug within 8 weeks prior to the screening visit.

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 ClinicalTrials.gov 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 |
Responsible Party: | G&E Herbal Biotechnology Co., LTD |
ClinicalTrials.gov 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 AK |
Additional relevant MeSH terms:
Keratosis Keratosis, Actinic Skin Diseases Precancerous Conditions Neoplasms |