Treatment of genital warts with Interferon alpha-2b Cream: a randomized, double blind, placebo-controlled study

Sponsors and Collaborators:	Helix Product Development (Ireland) Limited, a wholly-owned subsidiary of Intercon Pharma.
Information provided by:	Helix Product Development (Ireland) Limited, a wholly-owned subsidiary of Intercon Pharma.

RATIONALE: Currently, there are many treatments available for genital warts. Most rely on tissue destruction by physical ablation or cytotoxic chemicals, usually (but not exclusively) in a physician’s office. Among the various treatments, interferon alpha (like imiquimod), differs in that its action depends on immunomodulatory activities; however, the currently approved intralesional route of administration, like other therapeutic approaches, is painful and involves numerous visits to the physician’s office. Topical imiquimod is suitable for self-medication; however, due to its cytotoxic properties, it can be classified among the more painful and destructive approaches to genital wart removal.

Helix has developed a formulation of interferon alpha-2b that has been demonstrated to elicit a potent anti-viral effect. These results are encouraging from the point of view of developing a new, painless and convenient approach to the treatment of genital warts.

PURPOSE: To compare the efficacy and safety of topical Interferon alpha-2b Cream to vehicle for the treatment of condylomata accuminata in female patients.

Condition	Intervention	Phase
Ano-Genital Warts	Drug: Interferon Alpha-2b Cream Procedure: Topical Application	Phase II

Study Type: Interventional

Study Design: Prospective, double-blind, randomised, two groups (active and vehicle) multi-centre study. Only female patient treatment groups.

Official Title: Treatment of genital warts with Interferon alpha-2b Cream: A randomised, double-blind, placebo controlled study.

Start Date: December, 2006

Detailed Description:

OBJECTIVES:

Primary Endpoints:

• Proportion of patients with complete clearance of baseline warts in the ITT population.

OUTLINE (TRIAL DESIGN): This is a double blind, randomized, two groups (active and vehicle) multi-center study. Only female patient treatment groups. The study drug, Interferon alpha 2-b Cream, is a preparation of interferon alpha-2b for topical application to the external genital and perianal region based on Helix’ proprietary Biphasix™ drug formulation technology.

All patients will apply study cream to the external genital area twice daily, for 5 consecutive days, Monday through Friday. Patients will apply study cream for 8 weeks.

All the patients whose warts have resolved will be asked to attend a follow-up visit 8 weeks after their last treatment visit to evaluate the recurrence of baseline warts.

PROJECTED ACCRUAL: A total of 120 patients will be enrolled, 60 in each group.

Eligibility

Ages Eligible for Study:     18 Years and older
Genders Eligible for Study:     Female

Criteria
DISEASE CHARACTERISTICS: Human Papillomavirus (HPV) infections have reached epidemic proportions, with over 40 million people estimated to be infected in North America and Europe. HPV is the most common sexually transmitted disease in the world today, primarily affecting sexually active youth between the ages of 15-25, and is continuing to spread at a rate of over 5 million new cases each year in the US. The most common clinical manifestation of the virus is condylomata acuminate (genital warts).

Treatment options today are limited by pain and burning sensations, and are not always effective in clearing (treating) the wart or preventing wart recurrence. If opted for, these treatments include topical preparations (e.g. podophyllotoxin, Imiquimod), ablative surgical procedures (e.g. cryotherapy, excision, electrosurgery, laser surgery) and interferon alpha-2b injections on a visible wart-by-wart basis. All of these therapies are directed at the visible lesion (the words lesion and wart will be used interchangeably).


Often times, physicians will prefer to not treat a patient who presents with genital warts as the side effects of the approved treatments are worse than the manifestation of the warts. Warts can spontaneously regress if left untreated.


Investigators

Study Chair:
Pål Wälner-Hanssen, MD, Ph.D.
Department of Obstetrics and Gynecology
Univeristy Hospital of Lund, Sweden

More Information

Publications of Results: Not Available

Study ID Numbers:
Protocol Code Number: IFN001
EudraCT Number: 2005-000162-40


For more information or potential participation, please contact:
Encorium Sweden
Torshamnsgatan 28a
SE-146 40 Kista
Sweden
www.encorium.com
tel +46 8 5648 8270