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A Phase I/II, Open Labeled, Uncontrolled, Single Center Study of Topical AS101 for External Genital Warts

Phase 1/Phase 2
18 Years
Open (Enrolling)
Wart; External Genital Organs, Condyloma Acuminata

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Trial Information

A Phase I/II, Open Labeled, Uncontrolled, Single Center Study of Topical AS101 for External Genital Warts

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.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number of patients with Adverse Events and their severity

Outcome Time Frame:

up to 16 weeks

Safety Issue:


Principal Investigator

Shabtai Romano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ha'Emek Medical Center, Afula, Israel


Israel: Ministry of Health

Study ID:




Start Date:

March 2012

Completion Date:

March 2014

Related Keywords:

  • Wart; External Genital Organs
  • Condyloma Acuminata
  • Condylomata Acuminata
  • Warts