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thus , after injecting it intralesionally , a significant amount of the active drug is available for the action at the site , and so even a small amount is enough for treatment of warts .
we conducted a placebo - controlled trial of the intralesional injection of bleomycin in indian patients to know its efficacy in palmo - plantar and periungual warts which are usually difficult to treat with other modalities .
the present clinical trial was conducted between june 2009 and march 2010 in the department of dermatology .
a written informed consent was taken from all the patients and ethical clearance was obtained from appropriate authorities of the college .
fifty patients with multiple palmo - plantar and periungual warts of more than 3-month duration , without any history of previous treatment , whose age ranged from 15 to 40 years were included in the present study .
this age group was selected because multiple warts are common in this age group and these patients can be easily be counselled for follow - up .
pregnant women and patients with a history of raynaud 's disease or any other systemic illness were excluded from the study .
patients were categorized into two groups ( groups a and b ) of 25 each .
alternate patients were included in groups a and b which were treated with intralesional bleomycin and normal saline ( placebo ) , respectively .
it was diluted first with 5 ml distilled water to prepare the stock solution which can be stored for 60 days at 48c .
two parts of 2% lignocaine and one part of the bleomycin stock solution was taken in a tuberculin syringe , so that the final concentration became 1 mg / ml . each wart and the adjacent skin was cleansed with isopropyl alcohol .
superficial paring was done to remove the callus surrounding the wart ; bleeding points were not reached and the fresh solution was injected strictly intralesionally till blanching of the lesion occurred [ figure 1 ] .
the amount of the injection given depends on the size of warts : warts up to 5 mm , 10 mm and more than 10 mm received 0.2 ml , 0.5 ml and 1.0 ml , respectively .
the total volume injected at one treatment sitting was limited to 2 ml , and the injection into a single wart was limited to 1 ml . after 2 weeks of bleomycin injection , a black , ecchymosed eschar developed which was pared , and residual warts if present were injected a second time . in the controlled group , normal saline was injected in a similar manner as the bleomycin solution .
the patients were followed up weekly for first month , fortnightly up to 3 months and then quarterly up to 1 year .
a chi - square test was applied for statistical analysis using m - stat software .
routine haemogram , liver function tests , renal function tests and x - ray of the chest were done before and after 3 months of treatment .
one hundred and fifty - seven warts ( 157 ) were present in 50 patients which were included in the present study .
there were 27 males and 23 females whose mean age was 26.1 years and 29.2 years , respectively .
group a and b patients were having 85 and 72 warts , respectively [ table 1 ] .
the baseline parameters ( age , sex , sub - distribution of warts ) between the two groups were statistically comparable , and no significant statistical difference was observed .
a total of 82 ( 96.47% ) of the 85 warts treated with intralesional bleomycin in a dosage of 1 mg / ml in group a showed complete resolution after one or two injections within 12 weeks .
the response in periungual warts was 100% , while the response in palmo - plantar warts was 96.10% [ table 2 ] .
a total of 25 of the 85 warts in group a required a second injection .
nonresponders from the control group were treated later with intralesional bleomycin ( 1 mg / ml ) injection . in all the patients ,
warts regressed without any scarring but with a slight pigmentation that gradually faded during the follow - up of 1 year [ figure 2 , figures 3a  b ] .
none of the resolved wart recurred at the end of the 1-year follow - up .
of 72 warts treated with normal saline ( group b ) , only 8 ( 11.11% ) showed disappearance of the lesion within 3 months [ table 2 ] , but on further follow - up 19 ( 26.38% ) warts disappeared at the end of 1 year .
the difference in the resolution rate at the end of 12 weeks was statistically highly significant ( p = 0.001 ) between groups a and b. the ecchymosed eschar did not develop in warts treated with normal saline .
there was no change in haematological or biochemical investigation after 3 months of treatment in both groups .
most patients in both groups experienced moderate pain during injection that was of short duration and similar in both groups .
there was no effect on nail growth or nail dystrophy following intralesional injection around the nail .
number of patients and lesions at different sites in each group response of warts at different locations in groups a and b after 12 weeks multiple palmar warts before the initiation of treatment ( a ) partial improvement at the second week ; ( b ) complete resolution of warts without atrophy and hyperpigmentation after 6 weeks of intralesional bleomycin
common warts have been a frustration for both patients and clinicians since early greek and roman times .
they can greatly affect patient 's quality of life by causing embarrassment , fear of negative appraisal by others and frustration caused by persistence and/or recurrence .
warts may fail to clear even after repeated treatment with various physical modalities , and in the past , different studies have shown variable results with electrodissection , cryosurgery and different types of lasers .
previous studies on the intralesional bleomycin use have shown excellent results particularly in plantar and periungual warts .
bleomycin when used in high doses ( > 450 units ) as in cancer chemotherapy can cause pulmonary fibrosis . for a very low dose ( 1 mg / ml ) ,
we determined the efficacy of bleomycin in the treatment of warts at periungual and palmo - plantar sites which are difficult to treat with other modalities .
our results have shown a 96.10% cure rate in palmo - plantar warts which is higher than that ( 87% ) in a similar study conducted by salk and douglas . in 1983 ,
shumer and okeefe conducted a double - blind placebo - controlled study and treated 151 warts with intralesional bleomycin and 55 warts with normal saline as placebo .
their study showed a 60% cure rate for plantar warts and a 94% rate for periungual warts . the present study has shown a 96.10% clearance rate of palmo - plantar warts with intralesional bleomycin which is much higher than that in the above - mentioned study .
this may be due to the effect of paring which was done before injecting the second dose of intralesional bleomycin .
none of the placebo - treated warts cleared in the study conducted by shumer and okeefe while our study has shown an 11.11% cure rate at the end of 12 weeks .
olson reported the resolution of plantar warts in 18 of 25 ( 72% ) patients with bleomycin and 5 of 21 ( 27% ) patients treated similarly with placebo while our study showed a cure rate of 96.47% and 11.11% for the warts treated with bleomycin and normal saline as placebo , respectively , in 12 weeks .
dermojet was used by olson in his study , which can cause scattering of the solution and results in too small a dose being delivered within warts , which led to lower cure rates in the study .
hayes and okeefe reported a cure rate of 78% , much lower than that in the present study ; this may be due to the lower concentration of bleomycin used in their study .
bremner treated 142 warts in 24 patients with intralesional bleomycin and reported a 63% cure rate which is lower than that in our study .
the multiple - puncture technique using a bifurcated vaccination needle to introduce bleomycin in warts used by shelly and shelly in a study also mentioned a success rate of 92% .
potential side effects include scarring , change in pigmentation , nail damage and raynaud 's phenomenon were observed in few studies .
concentrations of bleomycin , such as 0.15% and 0.05% , had also been used to treat warts .
our results have shown bleomycin to be highly effective in the treatment of palmo - plantar and periungual warts .
the stock solution prepared in our study was more concentrated than the previous studies , and hence it was diluted with 2% lignocaine which also worked as a local anaesthetic and reduced localized pain during and after injection .
intralesional bleomycin injection was significantly safer and effective , with better patient acceptance in treating warts , particularly in palmo - plantar and periungual regions .
background / aim : intralesional bleomycin gained increasing popularity in the recent past for treatment of warts particularly in palmo - plantar and periungual regions as other modalities are not very effective . 
 hence we evaluated the role of intralesional bleomycin in periungual and palmo - plantar warts to know its efficacy in indian patients.settings and design : this was a placebo - controlled study.materials and methods : fifty patients of multiple palmo - plantar and periungual warts were included in this study and categorized in groups a and b of 25 each . 
 alternate patients were included in groups a and b and treated respectively with intralesional bleomycin ( 1 mg / ml solution ) and normal saline as placebo , fortnightly for maximum up to two injections . 
 patients were followed up weekly for 1 month , fortnightly up to 12 weeks , and then quarterly for 1 year . if warts persisted after 12 weeks of starting treatment , it was considered a failure . 
 statistical analysis was done by the chi - square test using m - stat software.results:group a and b patients were having 85 warts and 72 warts , respectively . 
 the cure rate in group a and b patients was 96.47% ( 82/85 warts ) and 11.11% ( 8/72 warts ) , respectively , after one or two injections within 12 weeks . 
 the difference in the cure rate between two groups was statistically highly significant ( < 0.0001 ) . in group a patients , a haemorrhagic eschar was formed which gradually healed in 8 - 12 weeks without atrophy or pigmentation ; 
 this phenomenon was not seen in group b. only moderate pain was observed by most of the patients during injection in both groups.conclusion:the intralesional injection of bleomycin is highly effective , safe , and non - toxic in periungual and palmo - plantar warts .