Study of Tuvatexib Ointment Compared to Placebo for Patients with Actinic Keratosis

2 1

What is this study about?

This clinical trial is studying actinic keratosis, a skin condition where rough, scaly patches develop on areas of skin that have been exposed to the sun over many years, typically on the face or scalp. These patches occur when skin cells grow abnormally due to sun damage and can sometimes develop into skin cancer if left untreated. The study will test a treatment called VDA-1102 ointment, which contains the active ingredient tuvatexib, and compare it to placebo ointment to see which works better at treating these skin patches.

The purpose of this study is to find out how well VDA-1102 ointment works compared to placebo ointment in treating a specific marker patch of actinic keratosis after twelve weeks of treatment. The marker patch is chosen as the one showing the most abnormal cell growth activity at the start of the study. During the trial, patients will apply the ointment to a specific area of their skin that contains several of these rough patches. The study will use a special imaging technique called LC-OCT, which is a type of scan that allows doctors to look at the deeper layers of skin without cutting into it, to measure changes in the skin patches.

Throughout the study, doctors will track several things including how many of the skin patches clear up completely or partially, changes in how the marker patch looks under the imaging scan, and the overall appearance of the treated skin area. Patients will apply the treatment for a period of twelve weeks, and doctors will monitor for any unwanted effects or reactions on the skin. The study may also include an optional skin sample taken from the marker patch to examine the tissue more closely under a microscope to better understand how the treatment is working at the cellular level.

1 Treatment period begins

The treatment phase starts after your enrollment in the trial. During this period, you will apply the assigned ointment to the designated treatment area on your face or scalp.

The treatment area will contain between 4 and 8 individual skin lesions, including one specific lesion that has been identified as the marker lesion. This marker lesion is the one with the highest level of abnormal cell activity at the start of the study.

You will be randomly assigned to receive either VDA-1102 ointment (containing the active substance tuvatexib) or a placebo ointment (which does not contain any active substance). Neither you nor the medical team will know which ointment you are receiving during the trial.

The ointment should be applied topically, meaning directly onto the skin surface of the treatment area.

This treatment period will last for 12 weeks.

2 Regular monitoring visits

Throughout the 12-week treatment period, you will attend scheduled visits for monitoring and assessment.

During these visits, the medical team will examine the treatment area and the marker lesion using a specialized imaging technique called LC-OCT (a type of optical scan that allows visualization of skin layers without cutting the skin).

The team will count the number of visible or touchable skin lesions in the treatment area to track changes over time.

Your skin reactions in the treatment area will be assessed and recorded. This includes checking for any redness, scaling, crusting, swelling, or other local skin changes.

Any side effects or health changes you experience will be documented as part of safety monitoring.

3 Assessment at 12 weeks

At the end of the 12-week treatment period, a comprehensive evaluation will be performed.

The marker lesion will be examined again using LC-OCT to measure changes in abnormal cell activity. This measurement uses a modified PRO score, which assesses the degree of rapidly dividing cells in the deeper layers of the skin.

The medical team will count all visible or touchable lesions in the treatment area to determine if there has been complete clearance (all lesions gone), partial clearance of 75% or more (at least three-quarters of lesions gone), or a different level of improvement.

The cosmetic appearance of the treated area will be assessed and compared to how it looked at the beginning of the study.

You may be asked to provide your assessment of the treatment product.

In some cases, an optional biopsy (removal of a small tissue sample for laboratory examination) of the marker lesion may be performed for additional analysis.

4 Safety monitoring throughout the trial

Throughout the entire trial period, any adverse events or serious adverse events will be carefully monitored and recorded.

Local skin reactions in the treatment area will be scored at each visit to track any irritation or other skin changes caused by the ointment application.

The treatment area will be examined for any signs of squamous cell carcinoma (a type of skin cancer). If any suspicious lesions are identified, they will be biopsied and examined under a microscope to confirm or rule out this condition.

Who Can Join the Study?

You must provide written informed consent, which means you agree in writing to take part in the study before any study activities begin.
You must be 18 years of age or older.
You must have a confirmed diagnosis of actinic keratosis, which are rough, scaly patches on the skin caused by sun damage, on your face or scalp.
You must have an AKASI score of at least 3.0. AKASI is a measurement system that calculates how widespread and severe your actinic keratosis patches are by looking at the affected area and thickness of the patches.
You must have at least one actinic keratosis lesion, which is a rough skin patch, with a PRO score of 2 or higher on your scalp or face. The PRO score is a measurement taken using a special imaging device called LC-OCT, which is a type of scan that looks at the layers of your skin.
Among your actinic keratosis patches with the highest PRO scores, the study doctor must be able to choose one patch that is suitable to be used as a marker lesion, which is a specific patch that will be closely monitored throughout the study to measure how well the treatment works.
The area around the chosen marker lesion must contain between 4 to 8 separate actinic keratosis patches, including the marker lesion itself. This area will be used as the study treatment area and must not have any other conditions that would prevent you from participating.
You must be able and willing to apply the study medication as instructed and follow all study instructions reliably throughout the study period.

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria (reasons why a patient cannot participate) for this clinical trial
Without detailed information about who should not join the study, it is not possible to list the specific conditions or situations that would prevent participation
The trial involves treatment with VDA-1102 ointment (a medication applied to the skin) for actinic keratosis (rough, scaly patches on the skin caused by sun damage)
The study accepts both male and female participants who are adults or elderly persons

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
CentroDerm GmbH	Wuppertal	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.01.2026

Trial locations

Investigated drugs:

TUVATEXIB

VDA-1102 ointment is an investigational topical treatment being studied for actinic keratosis, which are rough, scaly patches on the skin caused by sun damage. This ointment is applied directly to the skin to see if it can help treat these precancerous skin lesions. The study will compare how well this ointment works against a placebo ointment that contains no active medicine.

Investigated diseases:

Actinic keratosis

Actinic Keratosis – Actinic keratosis is a skin condition that develops due to prolonged exposure to ultraviolet radiation from the sun or artificial sources. It appears as rough, scaly patches on sun-exposed areas of the body, most commonly on the face, scalp, ears, neck, forearms, and back of the hands. The patches are typically dry and may be skin-colored, pink, red, or brown. The lesions can vary in size from very small to several centimeters in diameter. Over time, the affected areas may become thicker and more prominent. The condition progresses slowly and multiple lesions often develop in the same general area.

Trial ID:

2025-522482-30-00

Protocol code:

VDA-CP-06 P2B

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Tuvatexib Ointment Compared to Placebo for Patients with Actinic Keratosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?