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Can a shorter gel wait time still clear precancerous spots?

NCT ID NCT06507644

Disease control Sponsor: University of Nove de Julho Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether a lower-strength light-activated gel (8% vs. 16%) and a shorter wait time before red light treatment (1 hour vs. 3 hours) can effectively clear actinic keratoses—rough, precancerous spots caused by sun damage—on the face. Participants will receive one of four combinations, and researchers will track how many spots disappear completely over six months. The goal is to find a treatment that works well but is faster and possibly gentler.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a light-activated gel called methyl aminolevulinate (MAL) at 8% or 16% strength, followed by red light therapy
What this could lead to
If it works, this could point toward a shorter, more convenient treatment for precancerous sun-damaged skin spots on the face.
What could go wrong
This is a small, early-stage trial with only 4 participants per group, so results may not apply to everyone. The treatment can cause skin redness, pain, or blistering.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

4 people

The number who actually took part.

Started

Nov 2024

Finished

May 2026

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

40 to 90 years

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: * Individuals of both sexes, * Aged between 40 and 90 years, * Fitzpatrick skin phototypes I to IV, * Photodamaged skin with at least five clinically evident actinic keratosis lesions on the face to be treated, * No prior treatment for at least six months. Exclusion Criteria: * Clinically diagnosed infiltrative lesions, as the gold standard treatment is surgical with histopathological evaluation of the lesion (surgery will be performed at no cost to the participant), who will receive guidance and referral for appropriate treatment. * Photosensitive diseases, such as systemic lupus erythematosus, dermatomyositis, porphyria, among others. * History of arsenic exposure, * Known allergy to MAL or similar photosensitizing agents, * Psychoactive drug abuse, * Previous radiotherapy at the lesion site(s), * Participation in another clinical trial, * Intense tanning at the time of treatment, * Pregnant or breastfeeding women, * Local or systemic infection, * Immunosuppression: uncompensated chronic diseases or emotional disorders considered contraindications to treatment, * Skin conditions on the neck and anterior chest.

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Conditions

The condition(s) this trial relates to.

actinic keratosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Actinic keratoses

Contacts and locations

Locations

  • Anna Carolina R.T. Horliana

    São Paulo, São Paulo, 11030-480, Brazil

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