Sinecatechins ointment

What are catechins?

Catechins are chemical substances that occur naturally in green tea leaves. They have been studied in many areas of medicine and have been found to offer several therapeutic benefits. Researchers have noted their significant antioxidative, antiviral and immune-stimulatory properties.

What is sinecatechins ointment?

Sinecatechins 15% ointment, trade name Veregen®, is a botanical drug product for topical use in patients with genital and perianal warts. It was approved for prescription use in the United States in 2006, and is indicated for the treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients 18 years and older. Sinecatechins ointment is marketed in Spain, France, Austria and Serbia but is not yet available in New Zealand (August 2012).

The active ingredient is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze, and consists of a mixture of catechins and other green tea components. Veregen® is a registered trademark of MediGene AG, a pharmaceutical company in Germany. Veregen® is distributed in USA by PharmaDerm, A division of Fougera Pharmaceuticals Inc., Melville, New York.

How does sinecatechins ointment work?

It is unclear exactly how sinecatechins clear genital and anal warts. However, studies have shown that green tea extracts have antioxidative and antiviral properties and stimulate the immune system.

How is sinecatechins ointment used?

• Sinecatechins ointment is applied three times per day – in the morning, at noon and in the evening.
• A small amount of the ointment is applied to all warts. It should be dabbed on to ensure complete coverage and leaving a thin layer of the ointment on the warts.
• Hands should be washed before and after application.
• The ointment should not be washed off before the next application.
• When washing or bathing the treated area, the ointment should be applied afterwards.
• Treatment with sinecatechins ointment should be continued until complete clearance of all warts, or a maximum of 16 weeks.
• Sinecatechins ointment should not be applied on open wounds or inside the vagina or anus.
• Sexual contact should be avoided when sinecatechins ointment is on genital or perianal skin. The ointment must be washed off carefully before protected sexual contact, as the ointment may weaken condoms and vaginal diaphragms. After sexual contact, hands and the areas affected by warts should be washed with soap and water and the medication reapplied.

Who should not use sinecatechins ointment?

• Do not use sinecatechins ointment if allergic to an ingredient in the ointment.
• Women who are pregnant or are planning to become pregnant should consult with their doctor, as it is not known if sinecatechins ointment can harm the unborn baby.
• Breastfeeding; it is not known if sinecatechins ointment can pass into milk and if it can harm the baby.
• Sinecatechins ointment should not be used until the skin has healed from other treatments applied to the same area.
• People with weakened immune systems or taking immune suppressing medications, should not use the ointment.
• Do not expose skin treated with sinecatechins ointment to sunlight, sunlamps or tanning beds.

What are the possible side effects of sinecatechins ointment?

The most common side effects with sinecatechins ointment are local skin and application site reactions including:

• redness
• swelling
• sores or blisters
• burning
• itching
• pain.

Research evidence for sinecatechins ointment

Two randomized, double-blind, vehicle-controlled studies involving 600 patients have investigated the safety and efficacy of sinecatechins ointment in the treatment of immunocompetent patients 18 years of age and older, with external genital and perianal warts.

In the two clinical studies, 53.6% who applied sinecatechins ointment 3 times a day for up to 16 weeks showed complete clearance of external genital and anal warts. In these studies, treatment continued for 16 weeks or less, depending on how quickly the warts cleared.

In the clinical studies described above, patients who used sinecatechins ointment and had complete clearance of warts were re-checked 12 weeks after their treatment ended. More than 90% of these people had no recurrence of warts at that point in time.

Draft 7 August 2012