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Camellia Sinensis (Green Tea) Leaf Extract

This article discusses a clinical trial investigating the use of Camellia Sinensis (Green Tea) Leaf Extract, specifically Veregen® 10% ointment, for treating actinic keratosis on the scalp and face. The study aims to evaluate the efficacy and safety of this natural extract compared to a placebo in adult patients with mild to moderate actinic keratosis lesions.

Table of Contents

What is Camellia Sinensis (Green Tea) Leaf Extract?

Camellia Sinensis, commonly known as green tea, is a plant that has been used for centuries in traditional medicine. The leaf extract of this plant contains powerful compounds called catechins, which have shown promising medical properties. In recent years, researchers have been exploring the potential of green tea extract in treating various skin conditions, including actinic keratosis.[1]

Understanding Actinic Keratosis

Actinic keratosis (AK) is a skin condition that typically appears on areas of the body that have been exposed to the sun over many years, such as the face, scalp, and hands. These lesions are considered precancerous, meaning they have the potential to develop into skin cancer if left untreated. AK lesions often appear as rough, scaly patches on the skin and can vary in color from skin-toned to reddish-brown.[1]

Veregen® 10% Ointment: A Green Tea-Based Treatment

Veregen® 10% ointment is a medication that contains a defined extract of green tea leaves as its active ingredient. This ointment has been developed to treat actinic keratosis on the face and scalp. The green tea extract in Veregen® contains sinecatechins, which are believed to be responsible for its therapeutic effects.[1]

Clinical Study on Veregen® 10% Ointment

A large-scale clinical study is currently being conducted to evaluate the effectiveness and safety of Veregen® 10% ointment for treating actinic keratosis. This study is known as a Phase 3 trial, which is typically one of the final stages before a medication can be approved for widespread use.[1]

The study is designed as follows:

  • It is a multicenter study, meaning it’s being conducted at multiple medical facilities.
  • It is randomized, which means participants are randomly assigned to either receive the Veregen® ointment or a placebo (a similar ointment without the active ingredient).
  • It is placebo-controlled, allowing researchers to compare the effects of Veregen® to those of a placebo.
  • It is double-blind, meaning neither the participants nor the researchers know who is receiving the real treatment or the placebo during the study.

Efficacy of the Treatment

The main goal of this study is to determine if Veregen® 10% ointment is more effective than a placebo in treating actinic keratosis. The researchers are looking at several factors to measure the ointment’s effectiveness:[1]

  • Complete clearance: The primary measure of success is whether all visible AK lesions disappear after 12 weeks of treatment plus a 4-week follow-up period.
  • Partial clearance: They’re also looking at whether at least 75% of the lesions clear up.
  • Speed of clearance: How quickly the lesions disappear is another important factor.
  • New lesions: The study will track whether new AK lesions appear during treatment.
  • Long-term effects: The study includes a one-year follow-up period to see if the lesions return after treatment ends.

Safety and Side Effects

An important part of this study is to evaluate the safety of Veregen® 10% ointment. The researchers are carefully monitoring for any side effects or adverse reactions. They’re particularly interested in:[1]

  • Local skin reactions: How the skin in the treated area responds to the ointment.
  • Tolerability: How well patients tolerate the treatment, as assessed by both the doctors and the patients themselves.
  • Long-term safety: Any effects that might appear during the one-year follow-up period.
  • Risk of skin cancer: The study is monitoring for any cases of squamous cell carcinoma (a type of skin cancer) that might develop in the treated area or elsewhere on the head.

Who Can Use This Treatment?

The study has specific criteria for who can participate, which gives us an idea of who might be eligible for this treatment in the future if it’s approved. Potential candidates include:[1]

  • Adults aged 18 or older
  • People with 4-8 AK lesions on their face or bald scalp
  • Those with mild to moderate AK (classified as Olsen grade I or II)

However, this treatment may not be suitable for everyone. People with certain conditions or circumstances may not be eligible, including:[1]

  • Pregnant or breastfeeding women
  • People with a history of skin cancer
  • Those with other significant skin conditions in the treatment area
  • Individuals with certain medical conditions or taking specific medications

Conclusion

Camellia Sinensis (Green Tea) Leaf Extract, as formulated in Veregen® 10% ointment, shows promise as a treatment for actinic keratosis. The ongoing clinical study will provide valuable information about its effectiveness and safety. If successful, this green tea-based treatment could offer a new option for people dealing with actinic keratosis, potentially helping to prevent the progression to skin cancer. As always, it’s important to consult with a healthcare provider about the most appropriate treatments for your individual situation.[1]

Aspect Details
Study Type Phase 3, multicenter, randomized, placebo-controlled, double-blind
Treatment Veregen® 10% ointment (Green Tea Leaf Extract)
Condition Actinic Keratosis of the Scalp and/or Face
Primary Objective Complete clearance of lesions after 12 weeks of treatment and 4 weeks post-treatment
Treatment Duration 12 weeks
Follow-up Period 1 year post-treatment
Key Inclusion Criteria Adults ≥18 years, 4-8 AK lesions in 25 sq cm area, Olsen grade I or II
Key Exclusion Criteria Recent skin treatments, skin cancer history, significant medical conditions
Safety Assessments Adverse events, local skin reactions, tolerability, squamous cell carcinoma incidence

FAQ

  • What is actinic keratosis? Actinic keratosis is a skin condition characterized by rough, scaly patches on areas of the skin that have been exposed to the sun over time, such as the face and scalp. These lesions can potentially develop into skin cancer if left untreated.
  • How is green tea leaf extract used in this clinical trial? In this trial, green tea leaf extract is used in the form of Veregen® 10% ointment, which is applied topically to the affected areas of the scalp and face for a treatment period of 12 weeks.
  • What are the main goals of this clinical trial? The primary goal is to demonstrate the superiority of Veregen® 10% ointment over a placebo in completely clearing actinic keratosis lesions. Secondary goals include evaluating its efficacy in reducing lesion count, assessing skin reactions, and monitoring patient satisfaction.
  • Who can participate in this clinical trial? Adults aged 18 and older with mild to moderate actinic keratosis on the face or bald scalp, having 4 to 8 isolated lesions in a 25 square-cm area, are eligible. Participants must meet specific inclusion criteria and not have any exclusion factors.
  • How long does the study last? The study includes a 12-week treatment period, followed by a 4-week post-treatment period. After this, there is a 1-year post-treatment follow-up period to assess long-term effects and potential recurrence of lesions.

Ongoing Clinical Trials on Camellia Sinensis (Green Tea) Leaf Extract

  • Study on the Effectiveness of Green Tea Extract and Trichloroacetic Acid for Treating Anal High-Grade Squamous Intraepithelial Lesions in Adults

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness of Green Tea Leaf Extract Ointment for Adults with Actinic Keratosis on the Scalp and Face

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Actinic Keratosis (AK): A precancerous skin condition characterized by rough, scaly patches on sun-exposed areas of the body, such as the face and scalp.
  • Camellia Sinensis: The scientific name for the plant commonly known as green tea, whose leaf extract is being studied in this clinical trial.
  • Topical: A type of medication or treatment that is applied directly to the skin.
  • Placebo: An inactive substance or treatment used in clinical trials to compare the effects of a new drug or treatment.
  • Efficacy: The ability of a treatment to produce the desired beneficial effect.
  • Clinical clearance: The complete disappearance of visible or palpable signs of a skin condition.
  • Treatment area (TA): A specific area of the skin where the treatment is applied and evaluated during the clinical trial.
  • Olsen grade: A system used to classify the severity of actinic keratosis lesions.
  • AKASI: Actinic Keratosis Area and Severity Index, a tool used to assess the severity of actinic keratosis.
  • Post-treatment Follow-up (PTFU): The period after treatment has ended during which patients are monitored for long-term effects and potential recurrence.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-green-tea-leaf-extract-ointment-for-adults-with-actinic-keratosis-on-the-scalp-and-face/