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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01555112
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : August 15, 2013
Information provided by (Responsible Party):
BioMAS Ltd

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

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.

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01555112

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Gynecology department, Haemek MC
Afula, Israel
Sponsors and Collaborators
BioMAS Ltd
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Principal Investigator: Shabtai Romano, MD Ha'Emek Medical Center, Afula, Israel

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Responsible Party: BioMAS Ltd Identifier: NCT01555112     History of Changes
Other Study ID Numbers: AS101-IL#001
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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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