NCT00868088.

Trial name or title	A clinical trial of ALA photodynamic therapy for treatment of actinic cheilitis in patients with squamous cell carcinoma of the lip
Methods	This is a randomised, single‐blind, parallel‐assignment safety/efficacy study Aim: to determine whether ALA‐PDT applied to the lips can effectively clear actinic cheilitis (AC) and squamous cell carcinoma in situ of the lip
Participants	Inclusion criteria of the trial 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 Participants > 18 years of age Participants must be able to provide informed consent
Interventions	ALA‐PDT prior to surgery placebo and PDT prior to surgery
Outcomes	To determine whether preoperative treatment of the lips with ALA‐PDT can reduce the size of postsurgical defects in participants with actinic cheilitis and lip squamous cell carcinoma (primary outcome) To determine whether ALA‐PDT applied to the lips can effectively clear actinic cheilitis and squamous cell carcinoma in situ (secondary outcome)
Starting date	April 2009
Contact information	Tuffs Medical Centre Department of Dermatology (Gary Rogers, MD)
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