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document
Photodynamic therapy with 5-aminolaevulinic acid or placebo for recalcitrant foot and hand warts : randomised double-blind trial . BACKGROUND Photodynamic therapy ( PDT ) with topical 5-aminolaevulinic acid ( ALA ) followed by irradiation with incoherent light ( ALA-PDT ) for recalcitrant warts have had beneficial results . Therefore , we undertook a randomised , parallel , double-blind clinical trial of ALA-PDT versus placeboPDT for recalcitrant foot and hand warts . METHODS Recalcitrant foot and hand warts were randomly assigned to six repetitive ALA-PDT or placebo-PDT interventions combined with standard treatment encompassing paring followed by a keratolytic ( Verucid ) . Standardised photographs of each wart were taken before , during ( week 7 ) and after treatment ( weeks 14 and 18 ) . The area of each wart compared with entry area was the primary outcome variable , measured from photographs by an evaluator unaware of treatment allocation for intervention . Pain intensity immediately and 24 h after each intervention was assessed by a five-point scale . FINDINGS A total of 232 foot and hand warts in 45 patients were entered into the trial : 117 warts were allocated to ALA-PDT and 115 warts to placebo-PDT . In week 14 , the median relative reduction in wart area was 98 % in the ALA-PDT group ( interquartile range 100 % , 55 % ) versus 52 % ( 100 % , 0 ) in the placebo group ( p=0.0006 ) . In week 18 , the median relative reduction in wart area was 100 % in the ALA-PDT group ( 100 % , 57 % ) versus 71 % ( 100 % , 0 ) in the placebo-PDT arm ( p=0.008 ) . Both the number of vanishing warts and the difference in relative wart area of persisting warts at week 14 and 18 were significant ( p < 0.05 ) in favour of ALA-PDT . Significantly more ALA-PDT warts were graded at a higher pain intensity after treatment than placebo-PDT warts . INTERPRETATION ALA-PDT is superior to placebo-PDT when both wart area and number of vanishing warts are considered .
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Intervention_Control
Photodynamic therapy
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Intervention_Pharmacological
5-aminolaevulinic acid
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Intervention_Control
placebo
3401
Intervention_Pharmacological
Photodynamic therapy ( PDT ) with topical 5-aminolaevulinic acid ( ALA ) followed by irradiation with incoherent light ( ALA-PDT )
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Intervention_Pharmacological
ALA-PDT
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Intervention_Control
placebo-PDT
3404
Intervention_Pharmacological
ALA-PDT
3405
Intervention_Control
placebo-PDT
3406
Intervention_Pharmacological
ALA-PDT
3407
Intervention_Pharmacological
ALA-PDT
3408
Intervention_Control
placebo-PDT
3409
Intervention_Pharmacological
ALA-PDT
3410
Intervention_Control
placebo-PDT
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Intervention_Control
placebo-PDT
3412
Outcome_Physical
foot and hand warts :
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Outcome_Physical
area of each wart compared with entry area
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Outcome_Pain
Pain intensity
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Outcome_Physical
median relative reduction in wart area
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Outcome_Physical
median relative reduction in wart area
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Outcome_Other
number of vanishing warts
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Outcome_Other
difference in relative wart area of persisting warts
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Outcome_Pain
higher pain intensity
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Outcome_Physical
area and number of vanishing warts
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Participant_Condition
recalcitrant foot and hand warts
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Participant_Condition
Recalcitrant
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Participant_Condition
warts
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Participant_Sample-size
45