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

Actinic Keratosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516515
• Other study ID #: GESRTAKB
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: October 2018

Study information

• Verified date: December 2018
• Source: G&E Herbal Biotechnology Co., LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Vehicle gel
placebo
• SR-T100 with 2.3% of SM
2.3% of SM in Solanum undatum plant extract

Locations

Country	Name	City	State
United States	Suzanne Bruce and Associates,P.A. The Center for Skin Research	Katy	Texas
United States	IMMUNOe International Research Centers	Longmont	Colorado
United States	The Education & Research Foundation, Inc	Lynchburg	Virginia
United States	Pflugerville Dermatology Clinical Research	Pflugerville	Texas
United States	Contour Dermatology & Cosmetic Surgery Center	Rancho Mirage	California
United States	Premier Clinical Research	Spokane	Washington
United States	Atlantic Clinical Research Collaborative	West Palm Beach	Florida
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
G&E Herbal Biotechnology Co., LTD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total clearance rate:	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) .	8-week post-EOT visit (scheduled at Week 24 visit)
Secondary	Partial clearance rate	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).	24 week