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

Phase 2

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Vehicle gel; Drug: SR-T100 with 2.3% of SM

• Registration Number: NCT01516515
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Study Start: 2013-02
• Primary Completion: 2017-12
• Study Completion: 2018-10
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo, gel	Vehicle gel	placebo comparator
SR-T100 with 2.3% of SM, gel	SR-T100 with 2.3% of SM	2.3% of SM in Solanum undatum plant extract

Primary Outcome Measures

Name	Time	Method
Total clearance rate:	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

Name	Time	Method
Partial clearance rate	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).

Trial Locations

Locations (8)

Pflugerville Dermatology Clinical Research; 🇺🇸 Pflugerville, Texas, United States

The Education & Research Foundation, Inc; 🇺🇸 Lynchburg, Virginia, United States

Suzanne Bruce and Associates,P.A. The Center for Skin Research; 🇺🇸 Katy, Texas, United States

Premier Clinical Research; 🇺🇸 Spokane, Washington, United States

Atlantic Clinical Research Collaborative; 🇺🇸 West Palm Beach, Florida, United States

Contour Dermatology & Cosmetic Surgery Center; 🇺🇸 Rancho Mirage, California, United States

IMMUNOe International Research Centers; 🇺🇸 Longmont, Colorado, United States

Palm Beach Research Center; 🇺🇸 West Palm Beach, Florida, United States