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

Completed · Phase 2 · Has a placebo group

Conditions studied: Actinic Keratosis

In brief

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).

Key facts

Study ID

NCT01516515

Run by

G&E Herbal Biotechnology Co., LTD

People needed

86

Starts

2013-02-01

Expected to finish

2018-10-01

Last updated by the study team

2018-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.