Clinical trial NCT01516515: Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
AK
Lead sponsor: G&E Herbal Biotechnology Co., LTD
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Total clearance rate:
timeFrame: 8-week post-EOT visit (scheduled at Week 24 visit)
Secondary outcomes:
measure: Partial clearance rate
timeFrame: 24 week
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Contour Dermatology & Cosmetic Surgery Center
state: California
city: Longmont
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: West Palm Beach
country: United States
facility: Atlantic Clinical Research Collaborative
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Katy
country: United States
facility: Suzanne Bruce and Associates,P.A. The Center for Skin Research
state: Texas
city: Pflugerville
country: United States
facility: Pflugerville Dermatology Clinical Research
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
References: