Clinical trial · Interventional
Photodynamic Therapy to Treat Actinic Damage in Patients With Squamous Cell Carcinoma (SCC) of the Lip
A Clinical Trial of ALA Photodynamic Therapy for Treatment of Actinic Cheilitis in Patients With Squamous Cell Carcinoma of the Lip.
NCT00868088CI-TRIAL-00005170completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Our study is designed to evaluate the efficacy of photodynamic therapy (PDT) for treatment of actinic cheilitis (AC) and as an adjunct to Mohs surgery for squamous cell carcinoma (SCC) on the lips. This study will utilize an FDA approved PDT modality (DUSA, Inc., Wilmington, MA 01887) using topical 5-amino-levulinic acid (ALA) for photosensitization followed by exposure to a Blu-U light source emitting 405-420nm wavelength light.
Conditions
Conditions (5)
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 Cheilitis | — | UNRESOLVED | — |
| Mohs Surgery | — | UNRESOLVED | — |
| Photodynamic Therapy (PDT) | — | UNRESOLVED | — |
| Squamous Cell Carcinoma In-situ (SCC-is) | Squamous Cell Carcinoma In Situ | ONTOLOGY_EXACT | 0.85 |
| Squamous Cell Carcinoma (SCC) | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PDT prior to Mohs surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ALA + PDT
- description
- Topical ALA will be applied to the entire lip surface and allowed to incubate for 60 minutes plus or minus 30 minutes. Blue light at a wavelength of 405-420 nm will be used for treatment at a dose of 1000 seconds.
- interventionNames
- Procedure: PDT prior to Mohs surgery
- type
- PLACEBO_COMPARATOR
- label
- placebo + PDT
- description
- Topical placebo will be applied to the entire lip surface and allowed to incubate for 60 minutes plus or minus 30 minutes. Blue light at a wavelength of 405-420 nm will be used for treatment at a dose of 1000 seconds.
- interventionNames
- Procedure: PDT prior to Mohs surgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven squamous cell carcinoma of the lip * Greater than 50% of lip affected by actinic cheilitis by physical exam at time of initial evaluation. * Patients \> 18 years of age * Patients must be able to provide informed consent Exclusion Criteria: * Patients with history of photosensitivity * Patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease * Patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones) * Patients with hypersensitivity to porphyrins. * Women who are pregnant or nursing * No exclusion based on gender or race * Patients who have received anti-neoplastic treatment such as imiquimod or 5-FU to the lips within 30 days of enrolling in this study. * Patients simultaneously participating in another research study for management of SCC or actinic cheilitis * Subjects that plan to use other forms of AC treatment prior to Mohs. * Subjects that have an SCC requiring urgent (and sooner) Mohs surgery, including those tumors that are large (\> 2cm or at the discretion of the Principle Investigator) and those subjects that are pregnant or have palpable lymph nodes.
References
Publications (7)
- BACKGROUNDKubler AC, de Carpentier J, Hopper C, Leonard AG, Putnam G. Treatment of squamous cell carcinoma of the lip using Foscan-mediated photodynamic therapy. Int J Oral Maxillofac Surg. 2001 Dec;30(6):504-9. doi: 10.1054/ijom.2001.0160. PMID 11829232
- BACKGROUNDPiacquadio DJ, Chen DM, Farber HF, Fowler JF Jr, Glazer SD, Goodman JJ, Hruza LL, Jeffes EW, Ling MR, Phillips TJ, Rallis TM, Scher RK, Taylor CR, Weinstein GD. Photodynamic therapy with aminolevulinic acid topical solution and visible blue light in the treatment of multiple actinic keratoses of the face and scalp: investigator-blinded, phase 3, multicenter trials. Arch Dermatol. 2004 Jan;140(1):41-6. doi: 10.1001/archderm.140.1.41. PMID 14732659
- BACKGROUNDAlexiades-Armenakas MR, Geronemus RG. Laser-mediated photodynamic therapy of actinic cheilitis. J Drugs Dermatol. 2004 Sep-Oct;3(5):548-51. PMID 15552607
- BACKGROUNDSotiriou E, Apalla Z, Koussidou-Erremonti T, Ioannides D. Actinic cheilitis treated with one cycle of 5-aminolaevulinic acid-based photodynamic therapy: report of 10 cases. Br J Dermatol. 2008 Jul;159(1):261-2. doi: 10.1111/j.1365-2133.2008.08607.x. Epub 2008 Jul 1. No abstract available. PMID 18489592
- BACKGROUNDStender IM, Wulf HC. Photodynamic therapy with 5-aminolevulinic acid in the treatment of actinic cheilitis. Br J Dermatol. 1996 Sep;135(3):454-6. PMID 8949443
- BACKGROUNDKodama M, Watanabe D, Akita Y, Tamada Y, Matsumoto Y. Photodynamic therapy for the treatment of actinic cheilitis. Photodermatol Photoimmunol Photomed. 2007 Oct;23(5):209-10. doi: 10.1111/j.1600-0781.2007.00299.x. PMID 17803601
- BACKGROUNDBerking C, Herzinger T, Flaig MJ, Brenner M, Borelli C, Degitz K. The efficacy of photodynamic therapy in actinic cheilitis of the lower lip: a prospective study of 15 patients. Dermatol Surg. 2007 Jul;33(7):825-30. doi: 10.1111/j.1524-4725.2007.33176.x.