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Light-Activated cream could slow growth of NF1 skin tumors

NCT ID NCT02728388

Disease control Sponsor: Donald Basel 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Last updated Jul 10, 2026

Summary

This trial tests whether a light-activated cream (Levulan Kerastick) followed by red light therapy can slow the growth of benign skin tumors called neurofibromas in people with neurofibromatosis type 1 (NF1). About 30 participants aged 14 and older with superficial tumors on the trunk or limbs will receive either the active treatment or a placebo. The main goal is to see how long it takes for treated tumors to grow by 50% compared to untreated ones.

What this could mean

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

Active substance
aminolevulinic acid (Levulan Kerastick) with red light photodynamic therapy
What this could lead to
If it works, this could offer a non-surgical way to slow or stop the growth of painful or disfiguring skin tumors in people with NF1.
What could go wrong
This is a small early-phase trial, so results may not apply to everyone. The treatment may cause skin reactions and might not shrink existing tumors.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2016

Finished

Mar 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

14 to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Patient is 14 years or older. 2. Diagnosed NF1, determined by American Academy of Neurology Guidelines (see Diagnosis section). 3. Tumor Location: cutaneous, trunk, or limbs only. 4. Tumor Type: superficial dermal neurofibromas ≤4mm deep. 5. Patient has provided written informed consent. 6. Patient is willing to and can comply with study follow-up requirements. 7. Absence of any other malignancy. Exclusion Criteria: 1. Life expectancy less than 3 years. 2. Pregnancy. 3. Cutaneous photosensitivity to the wavelengths used to active PDT. 4. A diagnosis of porphyria. 5. Allergy to aminolevulinic acid or any of the topical solution vehicle components. 6. Previous chemotherapy within 6 weeks of proposed PDT. 7. Other concurrent tumor therapy.

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Conditions

The condition(s) this trial relates to.

neurofibroma neurofibromatosis type 1

As listed by the trial registrant

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

Neurofibromatosis 1

Contacts and locations

Locations

  • Donald G Basel

    Milwaukee, Wisconsin, 53226, United States

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