Safety and Efficacy Study to Test Topical AS101 for External Genital Warts

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to determine whether the improved topical ointment formulation, AS101, is safe and effective in the treatment of external genital warts in females.

Condition or disease	Intervention/treatment	Phase
Wart; External Genital Organs; Condyloma Acuminata	Drug: Topical AS101	Phase 1; Phase 2

Detailed Description:

Human papillomavirus (HPV)-induced condyloma acuminata (CA), commonly known as anogenital or genital warts, is among the most common sexually transmitted diseases. There are a wide variety of available treatments of genital warts, but none are considered completely effective. It has been suggested that AS101 works by stimulating the innate and acquired arms of the immune system.

In previous proof-of-concept clinical study AS101 topical cream was tested on HPV warts and shown cure in high percentages. However the cream formulation was unstable therefore a new formulation was developed mainly for the carrier. In this study the improved AS101 ointment will be tested in female patients with external genital warts in an open study to assess its safety and efficacy.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase I/II, Open Labeled, Uncontrolled, Single Center Study of Topical AS101 for External Genital Warts
Study Start Date :	March 2012
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	July 2013

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Topical AS101; 15% AS101 ointment applied twice a day for treatment of external genital warts.	Drug: Topical AS101; AS101 15% ointment will be applied topically twice daily on external genital warts for up to 16 weeks.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The number of patients with Adverse Events and their severity [ Time Frame: up to 16 weeks ]

Secondary Outcome Measures :

1. Number of patients with complete and partial clearance of external genital warts [ Time Frame: 16 weeks ]
2. Number of warts that were completely or partially cleared [ Time Frame: 16 weeks ]
3. Time to complete clearance [ Time Frame: 16 weeks ]
4. Recurrence rate in treatment area [ Time Frame: 3 months follow up ]
5. Time to recurrence [ Time Frame: 3 months follow up ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Women 18 years of age and in good health;
• Must sign an ethics committee approved informed consent form and be able to adhere to study visits and protocol requirements;
• Women must agree to avoid sexual contact while the ointment is on their skin;
• All study participants who are sexually active must use a barrier protection method of contraception such as condom in addition to another birth control measure such as oral contraceptives, intrauterine device, spermicide or surgical sterilization during treatment and for 60 days after completion of treatment;
• Patients with first clinical diagnosis of external genital warts, in the external genitalia including vulva (labia minora and majora), inguinal folds, pubic area, perineum, perianal, or buttocks areas;
• A minimum of one lesion and a maximum of 10 lesions identified at study entry, and the maximum diameter of the largest wart is no larger than 10 mm;
• Papanicolaou smears must be obtained in all females within 12 months of Day 1 and be negative for evidence of high grade intraepithelial neoplasia. Women with high grade intraepithelial neoplasia on cytology will be eligible if subsequent colposcopy with biopsy of suspicious area is negative for high grade squamous intraepithelial lesions (Grade 2 or 3). Atypia, HPV effect, and low grade intraepithelial lesions (Grade 1) are acceptable.

Exclusion Criteria:

• Participation in an investigational trial within 30 days prior to Day 1;
• Use of systemic steroids within 30 days of Day 1;
• Previous participation in a trial investigating AS101 for any indication.
• Any prior treatment for genital warts prior to participation;
• Topical and systemic immunosuppressive or immunomodulatory medications (including corticosteroids) within 30 days prior Day 1, and while on study;
• Known history of HIV, HBV and HCV viral infection.
• Current active infection with herpes genitalis or history of herpes genitalis infection within the last 30 days prior to Day 1 (patients on long-term suppressive antiviral therapy are eligible);
• Current and/or recurrent pathologically relevant genital infections other than genital warts;
• Diagnosis of high-grade cervical dysplasia;
• Internal anogenital, vaginal, urethral and cervical warts requiring treatment;
• Chronic or acute skin condition that might interfere with the evaluation of the treatment or study drug effect;
• Cutaneous surgery, including cryosurgery, to genital area within 30 days of Day 1;

• Screening laboratory tests results from a complete blood count (CBC), chemistry panel, urine pregnancy test and urinalysis obtained during screening (Day -14 to Day 0):

  • Must be within the site laboratory's defined normal reference ranges, and/or according to the Investigator's decision;
  • Urine pregnancy test in females of childbearing potential must be negative;
  • Inadequate renal function: Serum Creatinine > 2.0mg/dL (> 2.0 ULN);
  • Inadequate liver function: Serum (total) Bilirubin > 2 mg/dl or ALT and/or AST greater than two times the upper limit of the reference range.
• Uncontrolled infection or acute severe febrile illness;
• Diagnosed as having uncontrolled autoimmune disease;
• Pregnant or lactating;
• Current drug or alcohol abuse that may interfere with the objectives of the study;
• Known allergy to AS101 or any component of the investigational formulation;
• Subjects with any other clinically significant medical condition, psychiatric condition or laboratory abnormality which would, in the judgment of the Investigator, interfere with the subject's ability to participate in the trial.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Israel
Gynecology department, Haemek MC
Afula, Israel

Sponsors and Collaborators

BioMAS Ltd

Investigators

Principal Investigator:	Shabtai Romano, MD	Ha'Emek Medical Center, Afula, Israel

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	BioMAS Ltd
ClinicalTrials.gov Identifier:	NCT01555112 History of Changes
Other Study ID Numbers:	AS101-IL#001
First Posted:	March 15, 2012
Last Update Posted:	August 15, 2013
Last Verified:	August 2013

Additional relevant MeSH terms:

Warts; Condylomata Acuminata; Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Sexually Transmitted Diseases, Viral	Sexually Transmitted Diseases; Ammonium trichloro(dioxoethylene-O,O'-)tellurate; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Radiation-Protective Agents; Protective Agents