Double-blind, Placebo-Controlled, Randomized Exploratory Trial: Topical VDA-1102 Ointment in Rapidly Proliferating Actinic Keratosis
Actinic keratosis is a common skin condition caused by years of sun exposure. It leads to dry, scaly patches on sun-exposed areas like the face and scalp. If left untreated, some patches can occasionally turn into skin cancer. This early-stage clinical trial is testing a new experimental treatment called VDA-1102 ointment. Researchers want to find out how safe the ointment is and how well it clears fast-growing skin patches. Participants will be randomly chosen to apply either VDA-1102 or a matching dummy ointment (placebo) to their skin for 12 weeks. Doctors will track skin changes using a special, painless light scanner that looks closely at the skin layers without cutting. They will count the patches, check for skin reactions, and see if the appearance improves over time.
At a glance
What is this study about?
Actinic keratoses are rough, scaly patches that show up on areas of the body most exposed to sunlight, especially the face, forehead, and bald scalp. While many patches are harmless, some grow quickly and can gradually turn into a common form of skin cancer called squamous cell carcinoma. Because of this risk, doctors usually recommend treating them.
This trial is looking at an experimental skin treatment called VDA-1102 ointment. Scientists have designed this ointment to target fast-growing cells within sun-damaged patches. The main goal is to test how well the ointment works to shrink or clear these spots, and to check how safe and gentle it is on the skin.
To see if the treatment truly works, this is a 'placebo-controlled' study. This means half of the participants will receive the active VDA-1102 ointment, while the other half will receive an inactive dummy ointment that looks identical. Neither you nor your study doctor will know which one you are using until the study ends. This ensures the results are completely fair and unbiased.
Doctors will monitor the patches over 12 weeks. Instead of relying solely on regular skin biopsies, they will use an advanced, painless imaging device called LC-OCT. This scanner acts like a high-powered optical microscope, allowing the medical team to see deep into the skin cells in real time without causing any pain or scarring.
Key takeaways
- Tests a new ointment (VDA-1102) for fast-growing sun-damaged skin spots on the head or face.
- Compares the active ointment against an inactive dummy ointment (placebo) over 12 weeks.
- Uses advanced, painless light scanning to look inside skin cells without cutting.
- Open to adults aged 18 and over with actinic keratosis.
- Participation is entirely voluntary, and you can stop at any time.
Who may be eligible?
This trial is open to adults aged 18 and over of any sex who have noticeable actinic keratosis patches on their face or head. Doctors are specifically looking for people who have fast-growing or more active patches in these sun-exposed areas.
Because this study focuses on specific areas of the skin, participants will need to have at least one suitable patch on the head or face that the doctors can monitor closely with the skin scanner.
Certain health conditions, current skin treatments, or recent use of specific medications might mean this trial is not suitable for you. The clinical trial team will go through your complete medical history and examine your skin to ensure taking part is safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have rough, scaly, sun-damaged patches (actinic keratosis) on my face or scalp.
- I am able to apply a topical ointment to my skin regularly for 12 weeks.
- I can attend regular clinic appointments for skin checks and non-invasive scans.
- I am willing to follow the trial instructions and report any skin changes or side effects.
What does participation involve?
Taking part in this study lasts for around 12 weeks of treatment, plus initial screening and follow-up visits. If you join, you will be given an ointment to apply regularly to the affected skin at home as instructed by the medical team.
You will need to attend regular clinic appointments so doctors can check your progress. During visits, the team will examine your skin, count your patches, and take high-resolution non-invasive scans of a chosen 'marker' patch using a special light scanner. You might also be offered an optional, small skin biopsy (numbing the skin to take a tiny sample) to check the cells under a microscope. The team will ask about any side effects and check how your skin feels throughout the study.
Potential risks and benefits
Locations (1)
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Common questions
What is actinic keratosis?
It is a dry, scaly patch of skin caused by years of sun exposure. Doctors often treat it because a small number can turn into skin cancer over time.
What is a placebo?
A placebo is a dummy treatment that looks and feels just like the real medicine but contains no active ingredients. It helps scientists see if the real drug truly makes a difference.
Will the skin scans hurt?
No. The LC-OCT skin scanner uses harmless light beams to look beneath the surface of your skin. It is completely painless and does not break the skin.
Do I have to have a skin biopsy?
In this trial, having a skin biopsy to take a tiny tissue sample at the end of the treatment is optional. You can still participate even if you choose not to have one.
Can I leave the study if I get side effects?
Yes. You are free to stop the treatment and leave the study at any point. Your normal medical care will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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