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New light therapy could zap precancerous arm spots

NCT ID NCT07144852

Disease control Sponsor: Sun Pharmaceutical Industries, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a reformulated cream (Levulan Kerastick) plus blue light therapy for actinic keratosis, a common precancerous skin condition. About 260 adults with 4-8 spots on one arm will receive either the active treatment or a placebo cream, followed by light exposure. The main goal is to see if the spots completely clear up by week 12.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 260 people

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

Started

Nov 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 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 a male or non-pregnant female aged 18-85 years. 2. Patient must have 4-8 mild to moderate actinic keratosis (AK) lesions (Olsen grade 1 or 2) in a single treatment area on their Index arm, each measuring up to 1 cm in diameter and spaced at least 1 cm apart. \[The treatment area should be approximately 25 cm², located on the extensor surface of only one of the upper extremities that is selected as the Index arm\] 3. Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study. 4. Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an efficacy evaluation. 5. Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile. Exclusion Criteria: 1. Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area. 2. Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year. 3. History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins. 4. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result 5. Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects. 6. Use of specific topical therapies (e.g., retinoids, steroids, cryotherapy, PDT, chemical peels) on the treatment area within 2 days to 8 weeks prior to randomization. 7. Recent use of certain systemic therapies (e.g., corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization. 8. Recent use of hypericin or other phototoxic/photoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization. 9. Clinically significant or unstable illnesses, or history of alcohol/drug abuse in the past year. 10. Pregnancy/lactation, recent or current participation in another clinical study, or any other condition deemed unsuitable by the Investigator.

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Conditions

The condition(s) this trial relates to.

actinic keratosis precancerous condition skin disorder

As listed by the trial registrant

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

Actinic keratosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Arlington Dermatology

    RECRUITING

    Rolling Meadows, Illinois, 60008, United States

  • Center for Clinical and Cosmetic Research

    RECRUITING

    Aventura, Florida, 33180, United States

  • Center for Dermatology Clinical Research, Inc

    RECRUITING

    Fremont, California, 94538, United States

  • Clarity Dermatology, PLLC

    RECRUITING

    Castle Rock, Colorado, 80109, United States

  • Dermatology Associates of Knoxville

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Dermatology Associates of Plymouth Meeting

    RECRUITING

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Dermatology of Seattle & Bellevue

    RECRUITING

    Burien, Washington, 98168, United States

  • J&S Studies, Inc

    RECRUITING

    College Station, Texas, 77845, United States

  • Medical Dermatology Specialist

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Medisearch, LLC

    RECRUITING

    Saint Joseph, Missouri, 64506, United States

  • Minnesota Clinical Study Center

    RECRUITING

    New Brighton, Minnesota, 55112, United States

  • Northwest Clinical Trials, Inc.

    RECRUITING

    Boise, Idaho, 83704, United States

  • Oregon Dermatology and Research Center

    RECRUITING

    Portland, Oregon, 97210, United States

  • Palmetto Clinical Trial Services, LLC

    RECRUITING

    Anderson, South Carolina, 29621, United States

  • Palmetto Clinical Trial Services, LLC

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research

    RECRUITING

    Pflugerville, Texas, 78660, United States

  • Premier Clinical Research

    RECRUITING

    Spokane, Washington, 99202, United States

  • Tennessee Clinical Research Center

    RECRUITING

    Nashville, Tennessee, 37215, United States

  • The Indiana Clinical Trials Center, PC

    RECRUITING

    Plainfield, Indiana, 46168, United States

  • Ziaderm Research LLC

    RECRUITING

    North Miami Beach, Florida, 33162, United States

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