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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00868088
Other study ID # PDT for Lip
Secondary ID
Status Completed
Phase Phase 4
First received March 23, 2009
Last updated July 5, 2011
Start date July 2009
Est. completion date September 2010

Study information

Verified date July 2011
Source Tufts Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
PDT prior to Mohs surgery
Day 1: Screening and consent for this study. If eligible, a scouting biopsy will be obtained at 1 cm from the clinical border of the SCC for confirmation of AC. 7-14 Days after consultation: PDT to all subjects in the study. If during treatment a subject requests to discontinue due to pain the treatment will be terminated. 3-5 weeks after consultation: return for assessment. At this visit, the assigned treatment may be repeated if the treatment site is adequately healed. Re-treatment will only occur if there is persistent actinic damage. 6-8 weeks after consultation: Mohs surgery will be performed as per routine. Following tumor removal a scouting biopsy will be taken at a site 1 cm from the wound site created by SCC removal. The current waiting time for non-urgent surgery is 8 weeks. Standard care is not being altered for subjects in the study, other then their receiving the PDT intervention. Photographs may be taken at each subject visit.

Locations

Country Name City State
United States Tufts Medical Center, Department of Dermatology Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Tufts Medical Center DUSA Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary To determine whether pre-operative treatment of the lips with ALA PDT can reduce the size of post-surgical defects (scars) in patients with AC and lip SCC. at time of Mohs No
Secondary To determine whether ALA PDT applied to the lips can effectively clear actinic cheilitis (AC) and SCC in-situ (SCC-is) of the lip. at time of Mohs. No
Secondary To assess the tolerability of ALA PDT for treatment of AC and SCC-is of the lips at time of PDT and Mohs Yes
See also
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Terminated NCT04219358 - Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis Phase 1
Completed NCT00849992 - Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy Phase 4
Recruiting NCT06321003 - SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography
Recruiting NCT04744103 - Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis Phase 4
Completed NCT02198469 - Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis Phase 1
Withdrawn NCT03452566 - Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment Phase 1/Phase 2
Completed NCT02409732 - Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis Phase 4