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New combo treatment tackles sun damage and precancerous lesions in one go

NCT ID NCT07053852

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

10 people

The number who actually took part.

Started

Jun 2025

Finished

Dec 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.