A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.
This is a randomized, double-blind, placebo-controlled study. It will randomize patients in a 1:1 ratio to topical cervical treatment with A-007, or placebo gel. Following biopsy confirmation of High Grade Squamous Intraepithelial Lesions (HSIL), women will treat themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply gel once daily for 5 consecutive days of a 28-day cycle for 2 cycles. Women will return to clinic for safety assessments, colposcopy, cytology, and virologic and immunologic testing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
147
Pathological Response
Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.
Time frame: baseline and 4 months
Local Tolerability and Systemic Safety of A-007 Will be Assessed by Way of CTCAE 3.0.
Time frame: over the course of the trial
Eradication of Human Papilloma Virus (HPV) Will be Assessed by Way of Cervical Cytology and Swab Collection.
Time frame: over the course of the trial
Immunologic Parameters B/T Cells Will be Assessed by B/T Cell Profile Collection.
Time frame: over the course of the trial
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama Highlands, Dept. of OB/GYN
Birmingham, Alabama, United States
Hope Research Institute, LLC
Phoenix, Arizona, United States
Visions Clinical Research-Tucson
Tucson, Arizona, United States
Northern California Research Corp
Carmichael, California, United States
Arrowhead Regional Medical Center
Colton, California, United States
Robin Black OGNP
Costa Mesa, California, United States
IGO Medical Group of San Diego
San Diego, California, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Visions Clinical Research
Boynton Beach, Florida, United States
...and 19 more locations