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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Trial of the Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenyl-hydrazone (A-007) Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix

Phase 2
18 Years
Not Enrolling
Cervical Intraepithelial Neoplasia, Uterine Cervical Dysplasia

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Trial Information

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Trial of the Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenyl-hydrazone (A-007) Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix

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

Inclusion Criteria:

Patients may be enrolled in the study only if they meet all of the following criteria:

- 18 years of age or older

- The patient or her authorized representative must sign and date an Ethical Review
Board-approved informed consent document. All aspects of the protocol must be
explained and written informed consent obtained.

- Patients must have histological proof of HSIL (CIN 2/3) disease documented.

- Cervical swabs must test positive for HPV (by Hybrid Capture 2).

- Patients must have a Hb ≥ 9 g/dl, a peripheral WBC ≥ 3000 mm3 and platelet counts ≥
100,000 mm3.

- Normal hepatic and renal functions - AST and ALT < 2.5 x ULN and creatinine < 1.5 x
ULN, respectively.

- Females of childbearing potential must use one of the following birth control methods
during the treatment period and 2 weeks thereafter: oral, implantable, injectable
contraceptives; abstinence (celibacy). Contraceptive sponges, IUD, spermicides,
sponges, condoms, or partner's vasectomy are not acceptable methods of birth control.

Exclusion Criteria:

Patients will be excluded from the study for any of the following preexisting reasons:

- Patients with LSIL (CIN 1) or invasive squamous cell carcinoma (SCC).

- SIL (CIN) involving the endocervix as determined by endocervical curettage, or
otherwise not amenable to adequate colposcopic follow-up evaluations, i.e.
unsatisfactory colposcopy.

- CIN 3 involving more than two cervical quadrants on colposcopy.

- Patients treated for cervical SIL within the past year.

- Patients with other malignancy (except for non-melanoma skin) within the past 5

- Patients with any active infections (including HIV) other than HPV.

- Patients with known clinically relevant immunological deficiency.

- Concurrent treatment with cytotoxic, radiation, or immuno-stimulative therapy, or
with systemic corticosteroids at a dose of > 5 mg/d of prednisone (or its

- Participation in another investigational medication trial concurrently or within 30
days, or prior participation in an HPV vaccine trial. Treatment within the last 30
days with a medication that has not received regulatory approval at the time of study

- Concomitant use of topical vaginal medications.

- Significant acute or chronic medical or psychiatric illness that, in the judgment of
the Investigator, could compromise subject safety, limit the subject's ability to
complete the study, and/or compromise the objectives of the study.

- History of allergy or hypersensitivity to cosmetics, toiletries, or other topical or
dermatologic products.

- Pregnant or lactating females who are nursing and will not consent to cease nursing.

- Investigators, site personnel directly affiliated with this study, and their
immediate families. Immediate family is defined as a spouse, parent, child or
sibling, whether biological or legally adopted.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Pathological Response

Outcome Description:

Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.

Outcome Time Frame:

baseline and 4 months

Safety Issue:


Principal Investigator

John A Burigo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OB/GYN Specialists of the Palm Beaches


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

June 2008

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia (CIN)
  • High-grade Cervical Intraepithelial Neoplasia
  • High-grade Squamous Intraepithelial Lesions (HSIL)
  • Human Papilloma Virus (HPV)
  • High-Grade Cervical Intraepithelial Lesions (CIN 2/3)
  • Neoplasms
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ



Lehigh Valley Hospital Allentown, Pennsylvania  18103
Arrowhead Regional Medical Center Colton, California  92324-1819
Washington Hospital Center Washington, District of Columbia  20010
Medical College of Georgia Augusta, Georgia  30912
Jacobi Medical Center Bronx, New York  10461
South Carolina Oncology Associates Columbia, South Carolina  29201
Jersey Shore University Medical Center Neptune, New Jersey  07754
HOPE Research Institute, LLC Phoenix, Arizona  85032
Visions Clinical Research Boynton Beach, Florida  33472
University of Alabama Highlands, Dept. of OB/GYN Birmingham, Alabama  35205
Visions Clinical Research-Tucson Tucson, Arizona  85712
Northern California Research Corp Carmichael, California  95608
Robin Black OGNP Costa Mesa, California  92629
IGO Medical Group of San Diego San Diego, California  92121
Coastal Connecticut Research, LLC New London, Connecticut  06320
Global OB/GYN Centers of Florida Pembroke Pines, Florida  33024
Physician Care Clinical Research, LLC. Sarasota, Florida  34239
OB/GYN Specialists of the Palm Beaches West Palm Beach, Florida  33401
Mount Vernon Clinical Research, LLC Atlanta, Georgia  30328
East Jefferson OB/GYN Metairie, Louisiana  70006
Office of R. Garn Mabey, MD Las Vegas, Nevada  89128
Montefiore Medical Center-Weiler Division Dept of OB/GYN & Women's Health Bronx, New York  10461
New York Downtown Hospital New York, New York  10038
Greater Cincinnati OB/GYN, Inc. Cincinnati, Ohio  45267
University of Oklahoma Health Sciences Center Dept of OB/GYN Oklahoma City, Oklahoma  73104
Magee-Womens Hospital, Dept of OB/GYN & Reproductive Services Pittsburgh, Pennsylvania  15213
Hill Country OB/GYN Austin, Texas  78737
Planned Parenthood of Houston & Southeast Texas, Inc. Houston, Texas  77004
4601 Old Shepard Place; Bldg 2, Suite 201 Plano, Texas  75093