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

NCT01516515 | Completed Phase 2

• 1 other identifier: GESRTAKB
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 8

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).

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; AK

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Partial clearance rate

  24 week

Study Arms (2)

placebo, gel

PLACEBO COMPARATOR

placebo comparator

Drug: Vehicle gel

SR-T100 with 2.3% of SM, gel

ACTIVE COMPARATOR

2.3% of SM in Solanum undatum plant extract

Drug: SR-T100 with 2.3% of SM

Interventions

Vehicle gel DRUG

placebo

placebo, gel

SR-T100 with 2.3% of SM DRUG

2.3% of SM in Solanum undatum plant extract

Also known as: SR-T100

SR-T100 with 2.3% of SM, gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• G&E Herbal Biotechnology Co., LTD: lead

Study Sites (8)

Contour Dermatology & Cosmetic Surgery Center

Rancho Mirage, California, 92270, United States

Location

IMMUNOe International Research Centers

Longmont, Colorado, 80501, United States

Location

Atlantic Clinical Research Collaborative

West Palm Beach, Florida, 33406, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Suzanne Bruce and Associates,P.A. The Center for Skin Research

Katy, Texas, 77056, United States

Location

Pflugerville Dermatology Clinical Research

Pflugerville, Texas, 78660, United States

Location

The Education & Research Foundation, Inc

Lynchburg, Virginia, 24501, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

SR-T100

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 25, 2012
• Study Start: February 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: October 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

US (8)