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Treatment of skin papillomas with topical alpha-lactalbumin-oleic acid.

Gustafsson, Lotta LU ; Leijonhufvud, Irene LU ; Aronsson, Annika LU ; Mossberg, Anki LU and Svanborg, Catharina LU (2004) In New England Journal of Medicine 350(26). p.2663-2672
Abstract (Swedish)
Abstract in Undetermined

Background We studied the effect on skin papillomas of topical application of a complex of alpha-lactalbumin and oleic acid (often referred to as human alpha-lactalbumin made lethal to tumor cells [HAMLET]) to establish proof of the principle that alpha-lactalbumin-oleic acid kills transformed cells but not healthy, differentiated cells. Methods Forty patients with cutaneous papillomas that were resistant to conventional treatment were enrolled in a randomized, placebo-controlled, double-blind study, in which alpha-lactalbumin-oleic acid or saline placebo was applied daily for three weeks and the change in the volume of each lesion was recorded. After this first phase of the study, 34 patients... (More)
Abstract in Undetermined

Background We studied the effect on skin papillomas of topical application of a complex of alpha-lactalbumin and oleic acid (often referred to as human alpha-lactalbumin made lethal to tumor cells [HAMLET]) to establish proof of the principle that alpha-lactalbumin-oleic acid kills transformed cells but not healthy, differentiated cells. Methods Forty patients with cutaneous papillomas that were resistant to conventional treatment were enrolled in a randomized, placebo-controlled, double-blind study, in which alpha-lactalbumin-oleic acid or saline placebo was applied daily for three weeks and the change in the volume of each lesion was recorded. After this first phase of the study, 34 patients participated in the second phase, an open-label trial of a three-week course of alpha-lactalbumin-oleic acid. Approximately two years after the end of the open-label phase of the study, 38 of the original 40 patients were examined, and long-term follow-up data were obtained. Results In the first phase of the study, the lesion volume was reduced by 75 percent or more in all 20 patients in the alpha-lactalbumin-oleic acid group, and in 88 of 92 papillomas; in the placebo group, a similar effect was evident in only 3 of 20 patients (15 of 74 papillomas) (P<0.001). After the patients in the initial placebo group had been treated with α-lactalbumin-oleic acid in the second phase of the study, a median reduction of 82 percent in lesion volume was observed. At follow-up two years after the end of the second phase, all lesions had completely resolved in 83 percent of the patients treated with α-lactalbumin-oleic acid, and the time to resolution was shorter in the group originally assigned to receive α-lactalbumin-oleic acid than among patients originally in the placebo group (2.4 vs. 9.9 months; P<0.01). No adverse reactions were reported, and there was no difference in the outcomes of treatment between immunocompetent and immunosuppressed patients. Conclusions Treatment with topical alpha-lactalbumin-oleic acid has a beneficial and lasting effect on skin papillomas. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
New England Journal of Medicine
volume
350
issue
26
pages
2663 - 2672
publisher
Massachusetts Medical Society
external identifiers
  • pmid:15215482
  • wos:000222199000007
ISSN
0028-4793
language
English
LU publication?
yes
id
a1705c69-9c0a-4250-a0a7-de56d25fefcc (old id 123934)
alternative location
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15215482&dopt=Abstract
date added to LUP
2007-07-03 08:10:02
date last changed
2016-04-15 20:38:12
@article{a1705c69-9c0a-4250-a0a7-de56d25fefcc,
  abstract     = {<b>Abstract in Undetermined</b><br/><br>
Background We studied the effect on skin papillomas of topical application of a complex of alpha-lactalbumin and oleic acid (often referred to as human alpha-lactalbumin made lethal to tumor cells [HAMLET]) to establish proof of the principle that alpha-lactalbumin-oleic acid kills transformed cells but not healthy, differentiated cells. Methods Forty patients with cutaneous papillomas that were resistant to conventional treatment were enrolled in a randomized, placebo-controlled, double-blind study, in which alpha-lactalbumin-oleic acid or saline placebo was applied daily for three weeks and the change in the volume of each lesion was recorded. After this first phase of the study, 34 patients participated in the second phase, an open-label trial of a three-week course of alpha-lactalbumin-oleic acid. Approximately two years after the end of the open-label phase of the study, 38 of the original 40 patients were examined, and long-term follow-up data were obtained. Results In the first phase of the study, the lesion volume was reduced by 75 percent or more in all 20 patients in the alpha-lactalbumin-oleic acid group, and in 88 of 92 papillomas; in the placebo group, a similar effect was evident in only 3 of 20 patients (15 of 74 papillomas) (P&lt;0.001). After the patients in the initial placebo group had been treated with α-lactalbumin-oleic acid in the second phase of the study, a median reduction of 82 percent in lesion volume was observed. At follow-up two years after the end of the second phase, all lesions had completely resolved in 83 percent of the patients treated with α-lactalbumin-oleic acid, and the time to resolution was shorter in the group originally assigned to receive α-lactalbumin-oleic acid than among patients originally in the placebo group (2.4 vs. 9.9 months; P&lt;0.01). No adverse reactions were reported, and there was no difference in the outcomes of treatment between immunocompetent and immunosuppressed patients. Conclusions Treatment with topical alpha-lactalbumin-oleic acid has a beneficial and lasting effect on skin papillomas.},
  author       = {Gustafsson, Lotta and Leijonhufvud, Irene and Aronsson, Annika and Mossberg, Anki and Svanborg, Catharina},
  issn         = {0028-4793},
  language     = {eng},
  number       = {26},
  pages        = {2663--2672},
  publisher    = {Massachusetts Medical Society},
  series       = {New England Journal of Medicine},
  title        = {Treatment of skin papillomas with topical alpha-lactalbumin-oleic acid.},
  volume       = {350},
  year         = {2004},
}