PMID- 36040071
OWN - NLM
STAT- MEDLINE
DCOM- 20221220
LR  - 20221222
IS  - 1365-4632 (Electronic)
IS  - 0011-9059 (Linking)
VI  - 62
IP  - 1
DP  - 2023 Jan
TI  - Topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis caused 
      by Leishmania major: a double-blind, randomized, placebo-controlled, pilot study.
PG  - 40-47
LID - 10.1111/ijd.16407 [doi]
AB  - BACKGROUND: Cutaneous leishmaniasis (CL) topical treatments may have low 
      efficacy, while systemic treatments have adverse effects (AEs) and high cost. 
      Since treatment options for CL nowadays have numerous disadvantages, an 
      alternative topical treatment is vastly needed. We assessed liposomal 
      amphotericin B gel (LAmB gel) treatment efficacy and safety. METHODS: A 
      randomized, double-blind, placebo-controlled trial. Adults with CL (PCR proven, 
      </=5 lesions) were randomized for 28 days with LAmB gel (cases) versus placebo gel 
      (controls), followed by LAmB gel for 28 days (both groups). Lesion size, 
      ulceration, induration, scarring, swelling, and AEs (pain, itch, erythema, 
      discharge, fever, and urticaria) were assessed at days 1, 28, and 56. PCR was 
      repeated at day 56. RESULTS: Thirteen patients (four cases, nine controls) with 
      39 lesions (11 cases, 28 controls) caused by Leishmania major (L. major) were 
      randomized. Ulcer, induration, scarring, and swelling were noted in 18%, 91%, 0%, 
      and 27% of cases, respectively, versus 86%, 89%, 7%, and 54% of controls, 
      respectively. At day 28, improvement rates were low in both groups. Induration 
      improved comparing LAmB gel treatment for 56 days versus 28 days. Ulceration, 
      induration, and swelling improved comparing all patients at 56 days versus 
      28 days. PCR turned negative in three of four cases and eight of nine controls. 
      Mild, only local, AEs were reported in <30% of the patients. CONCLUSIONS: LAmB 
      gel is safe and may be considered as an alternative topical treatment for CL 
      caused by L. major. Further, larger-scale studies are warranted to evaluate the 
      long-term impact of LAmB gel on the management of CL.
CI  - (c) 2022 the International Society of Dermatology.
FAU - Horev, Amir
AU  - Horev A
AUID- ORCID: 0000-0001-6646-9061
AD  - Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, 
      Israel.
AD  - Pediatric Dermatology Service, Soroka University Medical Center, Beer Sheva, 
      Israel.
FAU - Sagi, Orli
AU  - Sagi O
AD  - Parasitology Laboratory, Soroka University Medical Center, Beer Sheva, Israel.
FAU - Zur, Eyal
AU  - Zur E
AD  - Compounding Solutions, Tel-Mond, Israel.
FAU - Ben-Shimol, Shalom
AU  - Ben-Shimol S
AUID- ORCID: 0000-0002-7690-0991
AD  - Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, 
      Israel.
AD  - Pediatric Infectious Disease Unit, Soroka University Medical Center, Beer Sheva, 
      Israel.
LA  - eng
GR  - Jewish National Fund/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220830
PL  - England
TA  - Int J Dermatol
JT  - International journal of dermatology
JID - 0243704
RN  - 0 (liposomal amphotericin B)
RN  - 0 (Antiprotozoal Agents)
RN  - 0 (Gels)
SB  - IM
MH  - Humans
MH  - *Leishmania major
MH  - Pilot Projects
MH  - *Antiprotozoal Agents/therapeutic use
MH  - Cicatrix/chemically induced
MH  - *Leishmaniasis, Cutaneous/drug therapy
MH  - Treatment Outcome
MH  - Gels/therapeutic use
EDAT- 2022/08/31 06:00
MHDA- 2022/12/21 06:00
CRDT- 2022/08/30 08:13
PHST- 2022/07/26 00:00 [revised]
PHST- 2022/05/19 00:00 [received]
PHST- 2022/08/10 00:00 [accepted]
PHST- 2022/08/31 06:00 [pubmed]
PHST- 2022/12/21 06:00 [medline]
PHST- 2022/08/30 08:13 [entrez]
AID - 10.1111/ijd.16407 [doi]
PST - ppublish
SO  - Int J Dermatol. 2023 Jan;62(1):40-47. doi: 10.1111/ijd.16407. Epub 2022 Aug 30.