PMID- 21103318
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20110714
LR  - 20211020
IS  - 1941-2789 (Print)
IS  - 1941-2789 (Linking)
VI  - 1
IP  - 2
DP  - 2008 Jul
TI  - Fluorouracil cream 0.5% for the treatment of actinic keratoses on the face and 
      anterior scalp: interim results of an 18-month open-label study.
PG  - 16-21
AB  - OBJECTIVE: This study further assessed the long-term safety and efficacy of 
      fluorouracil cream 0.5% in patients with multiple actinic keratosis (AK) on the 
      face/anterior scalp and other body sites. DESIGN/SETTING: This 18-month, 
      prospective, open-label, multicenter study comprised two treatment cycles 
      separated by 12 months. Cycle 1 included treatment of AK lesions on the face, 
      anterior scalp, posterior scalp, ears, neck, lips, arms, and/or hands. Once-daily 
      fluorouracil cream 0.5% was applied for four weeks as tolerated, followed by four 
      weeks of follow-up in each treatment cycle. PARTICIPANTS: Adults (N=277) with 
      five or more visible and/or palpable AK lesions on the face/anterior scalp and 
      five or more lesions on the posterior scalp, ears, neck, lips, arms, and/or hands 
      were enrolled. MEASUREMENTS: Main outcome measures included adverse events (AEs) 
      and reduction/clearance of AK lesions on the face/anterior scalp after four weeks 
      of treatment. RESULTS: RESULTS for treatment of AK lesions on the face/anterior 
      scalp for Cycle 1 are reported. All 277 patients were treated during Cycle 1. 
      Besides anticipated application-site reactions (67.9% and 19.1% of patients 
      experiencing mild-to-moderate and severe events, respectively) and eye 
      irritation, overall incidence of treatment-emergent AEs was low. No individual AE 
      appeared in greater than four percent of patients. At the end of Cycle 1, 
      significant reductions were noted in lesion counts on the face/anterior scalp 
      (84.8%; P<0.0001). Clearance rate for lesions on the face and anterior scalp was 
      39.8 percent at eight weeks. CONCLUSION: RESULTS indicate that fluorouracil cream 
      0.5% is safe and effective for patients with multiple AK lesions on the 
      face/anterior scalp.
FAU - Stough, Dow
AU  - Stough D
FAU - Bucko, Alicia D
AU  - Bucko AD
FAU - Vamvakias, George
AU  - Vamvakias G
FAU - Rafal, Elyse S
AU  - Rafal ES
FAU - Davis, Steven A
AU  - Davis SA
LA  - eng
PT  - Journal Article
PL  - United States
TA  - J Clin Aesthet Dermatol
JT  - The Journal of clinical and aesthetic dermatology
JID - 101518173
PMC - PMC2989824
EDAT- 2008/07/01 00:00
MHDA- 2008/07/01 00:01
PMCR- 2008/07/01
CRDT- 2010/11/25 06:00
PHST- 2010/11/25 06:00 [entrez]
PHST- 2008/07/01 00:00 [pubmed]
PHST- 2008/07/01 00:01 [medline]
PHST- 2008/07/01 00:00 [pmc-release]
PST - ppublish
SO  - J Clin Aesthet Dermatol. 2008 Jul;1(2):16-21.