PMID- 19326695
OWN - NLM
STAT- MEDLINE
DCOM- 20090508
LR  - 20191210
IS  - 0011-4162 (Print)
IS  - 0011-4162 (Linking)
VI  - 83
IP  - 2
DP  - 2009 Feb
TI  - A new ecamsule-containing SPF 40 sunscreen cream for the prevention of 
      polymorphous light eruption: a double-blind, randomized, controlled study in 
      maximized outdoor conditions.
PG  - 95-103
AB  - Polymorphous light eruption (PMLE) is an idiopathic photodermatosis elicited by 
      UV radiation (UVR). The objective of this double-blind, randomized, controlled, 
      intraindividual, bilateral comparison was to determine the efficacy of the UVA 
      filters (ecamsule, avobenzone) present in the new sun protection factor (SPF) 40 
      sunscreen cream in preventing PMLE in maximized outdoor conditions (ie, 
      exaggerated sun exposure). Safety also was assessed. Each participant was treated 
      with SPF 40 sunscreen cream containing ecamsule 3%, octocrylene 10%, avobenzone 
      2%, and titanium dioxide 5% (tetrad) on one side of the body and either an 
      ecamsule-deprived (triad-E) or avobenzone-deprived (triad-A) cream on the other 
      side. Participants were subsequently exposed to incremental doses of sunlight for 
      up to 6 days. The primary efficacy assessment was a composite relative success 
      rate with 3 components. Success was defined as either a delayed time to onset of 
      PMLE or a lower global severity of PMLE comparing one side of the body to the 
      other side in the same participant. Safety evaluations included systemic adverse 
      events (AEs). Of the 144 participants enrolled and randomized, 22 did not 
      experience PMLE during the study duration under these maximized sun exposure 
      conditions. A significantly greater number of successes were detected on the 
      tetrad-treated side compared with either triad: 41 of 73 participants (56%) 
      versus 8 of 73 participants (11%; P<.001) in the triad-E treatment group and 26 
      of 71 participants (36%) versus 11 of 71 participants (16%; P=.02) in the triad-A 
      treatment group. Polymorphous light eruption appeared later with the tetrad than 
      with either triad. The global severity of the PMLE flares was significantly lower 
      with the tetrad than with both triads at end point (P<.001 and P=.02 for tetrad 
      vs triad-E and tetrad vs triad-A, respectively). In this study, the SPF 40 
      sunscreen cream containing ecamsule 3%, octocrylene 10%, avobenzone 2%, and 
      titanium dioxide 5% prevented PMLE flares significantly better than similar 
      formulations with only one of the UVA filters (triad-E treatment group, P<.001; 
      triad-A treatment group, P=.02). The inclusion of both ecamsule and avobenzone 
      provides clinical benefit to patients with PMLE compared with formulations 
      containing only one UVA filter.
FAU - DeLeo, Vincent A
AU  - DeLeo VA
AD  - St. Luke's-Roosevelt Hospital Center, 1090 Amsterdam Ave, Suite 11D, New York, NY 
      10025, USA. vdeleo@chpnet.org
FAU - Clark, Scott
AU  - Clark S
FAU - Fowler, Joseph
AU  - Fowler J
FAU - Poncet, Michel
AU  - Poncet M
FAU - Loesche, Christian
AU  - Loesche C
FAU - Soto, Pascale
AU  - Soto P
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Cutis
JT  - Cutis
JID - 0006440
RN  - 0 (Camphanes)
RN  - 0 (Chalcones)
RN  - 0 (Propiophenones)
RN  - 0 (Sulfonic Acids)
RN  - 0 (Sunscreening Agents)
RN  - 0 (terephthalylidene dicamphor sulfonic acid)
RN  - G63QQF2NOX (avobenzone)
SB  - IM
MH  - Administration, Topical
MH  - Adult
MH  - Camphanes/*administration & dosage
MH  - Chalcones/*administration & dosage
MH  - Dermatitis, Photoallergic/*prevention & control
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Propiophenones
MH  - Statistics, Nonparametric
MH  - Sulfonic Acids/*administration & dosage
MH  - Sunscreening Agents/*administration & dosage
MH  - Treatment Outcome
EDAT- 2009/03/31 09:00
MHDA- 2009/05/09 09:00
CRDT- 2009/03/31 09:00
PHST- 2009/03/31 09:00 [entrez]
PHST- 2009/03/31 09:00 [pubmed]
PHST- 2009/05/09 09:00 [medline]
PST - ppublish
SO  - Cutis. 2009 Feb;83(2):95-103.