PMID- 24509967
OWN - NLM
STAT- MEDLINE
DCOM- 20141006
LR  - 20181202
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 13
IP  - 2
DP  - 2014 Feb
TI  - Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: two phase 3, 
      multicenter, randomized, double-blind, placebo-controlled studies.
PG  - 166-9
AB  - BACKGROUND: Imiquimod 3.75% and 2.5% creams were studied for the treatment of 
      actinic keratosis (AK) of the full face or balding scalp, to determine comparable 
      efficacy and tolerability to imiquimod 5% cream. METHODS: In two identical 
      multicenter, randomized, double-blind, placebo controlled studies. Adult subjects 
      with 5 to 20 visible lesions, or palpable AKs in an area that exceeded 25 cm(2) on 
      either the face or balding scalp were randomized to imiquimod 3.75%, 2.5% or 
      vehicle cream (1:1:1) applied once daily for two 2-week treatment cycles, with a 
      2-week, no-treatment interval between cycles. Efficacy was assessed 8 weeks 
      posttreatment (End of Study Visit [EOS]). Primary efficacy was rate of complete 
      clearance of AK lesions. Secondary efficacy endpoints were rate of partial 
      clearance at EOS (>/= 75% reduction in number of AK lesions compared to baseline) 
      and median percent decrease from baseline lesion count. Safety assessments 
      included visual assessment of local skin reactions (LSRs), number and duration of 
      study treatment rest periods required due to intolerant LSRs, adverse events 
      (AEs) and clinical laboratory tests. RESULTS: Overall 479 patients were 
      randomized to imiquimod 3.75%, 2.5%, or vehicle. Complete clearance rates were 
      35.6%, 30.6%, and 6.3% respectively (both P<.001 versus vehicle). The difference 
      in complete clearance rates (imiquimod minus vehicle) was 29.3% and 24.3%, 
      respectively. Partial clearance rates were 59.4%, 48.1%, and 22.6% respectively 
      (both P<.001 versus vehicle). Median % reductions in AK lesions were 81.8%, 
      71.8%, and 25.0% respectively (P<.001 versus vehicle). All primary and secondary 
      efficacy endpoints were greater in Study 1. Photodamage in the treatment area was 
      'much improved' with imiquimod 3.75%. Both active creams were well tolerated with 
      few treatment-related discontinuations. CONCLUSIONS: In two well-controlled Phase 
      3 studies, both imiquimod 3.75% and 2.5% creams were more effective than vehicle 
      and well tolerated when administered daily as a 2-week on/off/on regimen to treat 
      AK. Reduction in AK lesions was comparable to that reported with imiquimod 5% 
      with fewer local AEs.
FAU - Swanson, Neil
AU  - Swanson N
FAU - Smith, Christina Cognata
AU  - Smith CC
FAU - Kaur, Mandeep
AU  - Kaur M
FAU - Goldenberg, Gary
AU  - Goldenberg G
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Aminoquinolines)
RN  - P1QW714R7M (Imiquimod)
SB  - IM
MH  - Adjuvants, Immunologic/administration & dosage/*therapeutic use
MH  - Adult
MH  - Aminoquinolines/administration & dosage/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Face
MH  - Female
MH  - Humans
MH  - Imiquimod
MH  - Keratosis, Actinic/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Scalp
MH  - Skin Aging/drug effects
MH  - Treatment Outcome
EDAT- 2014/02/11 06:00
MHDA- 2014/10/07 06:00
CRDT- 2014/02/11 06:00
PHST- 2014/02/11 06:00 [entrez]
PHST- 2014/02/11 06:00 [pubmed]
PHST- 2014/10/07 06:00 [medline]
AID - S1545961614P0166X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2014 Feb;13(2):166-9.