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

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What is this study about?

This clinical trial is focused on studying Actinic Keratosis, a skin condition that often appears as rough, scaly patches on the skin, particularly on areas frequently exposed to the sun, like the scalp and face. The study is testing the effectiveness and safety of a treatment called Veregen 10% Ointment, which contains an active ingredient derived from green tea leaves. This ointment will be compared to a placebo, which looks similar but does not contain the active ingredient.

The purpose of the study is to determine if Veregen 10% Ointment is more effective than the placebo in completely clearing the affected skin areas. Participants will apply the ointment to the affected areas for a period of 12 weeks, followed by a 4-week observation period. During this time, the study will monitor the skin for any changes, aiming for complete disappearance of the Actinic Keratosis patches.

Throughout the study, participants will have regular check-ups to assess the condition of their skin and to ensure their safety. The study will also continue to monitor participants for a year after the treatment to observe any long-term effects or recurrence of the skin condition. This trial aims to provide valuable information on the potential benefits of using Veregen 10% Ointment for treating Actinic Keratosis on the scalp and face.

1 joining the study

Upon joining the study, the patient is required to provide written informed consent, confirming their willingness to participate.

The patient must be at least 18 years old and have a clinically confirmed diagnosis of mild to moderate actinic keratosis on the face or bald scalp.

2 treatment period

The patient will apply Veregen 10% ointment or a placebo ointment to the affected area. The ointment is applied topically, meaning it is used directly on the skin.

The treatment period lasts for 12 weeks. During this time, the patient will have on-site visits at 2, 4, 8, and 12 weeks to monitor progress.

3 post-treatment period

After completing the 12-week treatment, there is a 4-week post-treatment period. This period allows for further observation of the treatment’s effects.

The primary goal is to achieve complete clearance of the actinic keratosis lesions in the treated area.

4 follow-up period

Following the post-treatment period, a 1-year follow-up period is conducted to monitor the long-term effects of the treatment.

During this time, the patient will have visits at 8 weeks post-treatment, and then at 3, 6, 9, and 12 months post-treatment.

5 safety and efficacy assessments

Throughout the study, the patient will be assessed for any adverse events or side effects related to the treatment.

The efficacy of the treatment will be evaluated by measuring the reduction or clearance of actinic keratosis lesions.

Who Can Join the Study?

Patients must be willing to participate and provide written consent, which means they agree to join the study after understanding what it involves.
Participants can be male or female and must be at least 18 years old.
Participants need to have a confirmed diagnosis of mild to moderate Actinic Keratosis (AK), which is a skin condition, on the face (including the forehead but not the eyelids, lips, or inside the mouth) and/or the bald scalp.
Participants should have between 4 and 8 separate AK lesions, which are small areas of skin damage, in a treatment area on the face and/or bald scalp that is 25 square centimeters in size.
The AK lesions in the treatment area must be typical and classified as Olsen grade I or Olsen grade II, which are specific types of this skin condition.
Participants must be able to follow the study instructions and are likely to complete all the study requirements.

Who Cannot Join the Study?

Patients who do not have Actinic Keratosis (AK) on the scalp or face cannot participate. Actinic Keratosis is a rough, scaly patch on the skin caused by sun exposure.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not willing or able to follow the study procedures and requirements cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have used certain medications or treatments that might affect the study results cannot participate.
Patients who have a history of allergic reactions to the study medication or similar products cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Praxis Dr. med. Abdou Zarzour	Halle (Saale)	Germany
Studienzentrum Dr. Beate Schwarz	Langenau	Germany

Other Sites

Site Name	City	Country
Hautarztpraxis Dr. Wilfried Steinborn	Straubing	Germany
St. Josef-Hospital	Bochum	Germany
ZENTderma	Moenchengladbach	Germany
Hautarztzentrum Hamm	Hamm	Germany
Proderma Duelmen	Duelmen	Germany
Gemeinschaftspraxis Weber & Crainic	Augsburg	Germany
Tugrkpeqdgr ulu Sddvwhongpj Bbcbuwqi Gluh	Bad Bentheim	Germany
Damxtufweqji Qqzom	Mainz	Germany
Hslg Hjfjl udv Lxnllfldokvd Parqhet	Potsdam	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	02.10.2023

Trial locations

Investigated drugs:

Camellia Sinensis (Green Tea) Leaf Extract

Sinecatechins: This is an ointment made from a defined extract of green tea leaves. It is used in this study to treat actinic keratosis, which is a skin condition that can develop into cancer if left untreated. The ointment is applied to the affected areas on the scalp and face to see if it can completely clear the condition after a 12-week treatment period, with an additional 4-week follow-up.

Investigated diseases:

Actinic keratosis

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, such as the scalp and face. It occurs when skin cells are damaged by ultraviolet (UV) radiation, leading to abnormal growth. The patches can vary in color, appearing pink, red, or brown, and may feel dry or rough to the touch. Over time, these lesions can become more pronounced and may increase in number. While they are generally not painful, they can cause discomfort or itching. If left untreated, there is a potential for these lesions to develop into more serious skin conditions.

Trial ID:

2022-502811-12-00

Protocol code:

Pro_VER-01-21_AR

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

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