New combo treatment tackles sun damage and precancerous lesions in one go
NCT ID NCT07053852
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This small study tested whether a gel called Ameluz, activated by a special broadband light (BBL), can treat both actinic keratoses (rough, scaly spots that can turn into skin cancer) and general sun damage on the face. Ten adults with mild to moderate skin damage received two treatments. Researchers measured how many spots cleared up and how much the skin's appearance improved after one and two months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ameluz (a gel applied to the skin) plus broad band light (BBL) therapy
- What this could lead to
- If it works, this could offer a single treatment that both clears precancerous skin spots and improves sun-damaged skin appearance.
- What could go wrong
- This is a very small, early Phase 1 trial with only 10 people. Results may not apply to everyone, and long-term safety or effectiveness is not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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10 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Over 18yrs of age * Willingness to participate in all required study activities and visits * Willingness to sign the informed consent form * Visible and palpable signs of diffuse actinic damage and actinic keratoses of mild to moderate severity located on the face * Significant signs of photoaging, evaluated by investigator, that include any or all the following: * Dyspigmentation * Solar lentigines * Telangiectasias * Diffuse erythema * Roughness and other textural changes * Fine lines * Wrinkles * Actinic bronzing Exclusion Criteria: * Subject who is unable and unwilling to provide consent for study schedule and procedures * Subject who is pregnant or trying to become pregnant during the study * Subjects using any topical treatment on their AKs; must stop at least one month prior * Subjects currently undergoing cancer treatment with medical or radiation therapy * Subjects with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material * Subjects with history of a photosensitivity disease, such as porphyria cutanea tarda
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Rochester Dermatologic Surgery
Victor, New York, 14564, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Two-Drug cream clear precancerous skin spots even when immunity is suppressed?
- Can a shorter gel wait time still clear precancerous spots?
- Laser rejuvenation may shield aging skin from cancer
- Laser resurfacing may shield aging skin from cancer
- Shorter wait for light therapy? study tests faster treatment for Sun-Damaged skin
- Light therapy vs chemical peels: which zaps precancerous spots better?