Clinical trial · Interventional
Daylight Photodynamic Therapy for Actinic Keratosis
Tolerability and Efficacy of Daylight Aminolevulinic-acid-photodynamic Therapy (ALA-PDT) Compared With Conventional ALA-PDT for Treatment of Actinic Keratosis on the Face or Scalp
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, single-blind controlled trial with parallel group design to determine whether daylight photodynamic therapy (PDT) affords a reduction in treatment symptoms of pain, burning, and pruritus as measured by 1) symptom level during the treatment period and 2) pain at the end of treatment exposure.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic Acid Topical 20% Topical Solution | Drug | Aminolevulinic Acid | ALIAS |
| BLU-U blue light phototherapy illuminator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A. Conventional arm
- description
- This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator
- interventionNames
- Drug: Aminolevulinic Acid Topical 20% Topical Solution
- Device: BLU-U blue light phototherapy illuminator
- type
- EXPERIMENTAL
- label
- B. Combination arm
- description
- This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults at least 18 years old. * Subjects must be able to read, sign, and understand the informed consent * Subjects have at least 4 and no more than 20 clinically typical, visible actinic keratoses in the target treatment area on the face or scalp. * Subject must be willing to forego any other treatments for AK in the treatment area on the face or scalp, during the study period, and for 14 days prior to screening; including cryotherapy, topical 5-fluorouracil, imiquimod, and ingenol mebutate. * Subjects who have previously received PDT must undergo at least an 8-week washout period prior to enrollment in study. * Subject must be willing and able to participate in the study and to comply with all study requirements including concomitant medication and other treatment restrictions, and telephone interview. * If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study. Women who are pregnant, lactating, or planning to become pregnant during the study period are excluded from the study. Exclusion Criteria: * Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs. * Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation. * Subjects with any medical condition that, in the opinion of the investigator, makes the patient unsuitable for the trial.
References
Publications (0)
Data not yet available