PMID- 34152880
OWN - NLM
STAT- MEDLINE
DCOM- 20220117
LR  - 20220426
IS  - 1556-9535 (Electronic)
IS  - 1556-9527 (Linking)
VI  - 40
IP  - 3
DP  - 2021 Sep
TI  - Efficacy of topical Lawsonia inermis L. (Henna) hydrogel in fluorouracil-induced 
      hand-foot syndrome: a pilot randomized double-blind placebo-controlled clinical 
      trial.
PG  - 257-262
LID - 10.1080/15569527.2021.1940194 [doi]
AB  - PURPOSE: Hand-foot syndrome (HFS) is a frequent dose-limiting adverse reaction of 
      fluoropyrimidine drugs like capecitabine and 5-flourouracil (5-FU) in breast and 
      gastrointestinal cancers. It has been shown that conventional application of 
      Lawsonia inermis L. (Henna) is effective in ameliorating of the skin lesions. To 
      increase the patient compliance, in this study we formulated a standardized 
      topical hydrogel (H.gel) containing the hydroalcoholic extract (10%) of Henna and 
      evaluated its clinical efficacy for the management of fluorouracil associated 
      HFS. MATERIAL AND METHODS: The topical dosage form was standardized based on its 
      Lawsone content. Eighteen patients suffering from HFS were randomized to receive 
      H.gel and the placebo four times a day for 2 weeks. At the baseline and at the 
      end of the trial, HFS grades were determined. RESULTS AND CONCLUSIONS: Allergic 
      reactions following administration of H.gel were observed in one patient, while 
      no serious adverse events occurred in the others. No statistically significant 
      differences between two arms were observed at the baseline (p-value = 0.133), 
      after treatment (p-value = 0.590) and grade differences (p-value = 0.193). The 
      applied hydrogel showed less efficacy compared to the traditional method of using 
      Henna, meaning that Lawsone may not be a good indicator for standardizing the 
      topical dosage form.
FAU - Mohajerani, Razieh
AU  - Mohajerani R
AD  - Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, 
      Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
FAU - Shahi, Farhad
AU  - Shahi F
AD  - Breast Disease Research Center, Tehran University of Medical Science, Tehran, 
      Iran.
FAU - Jafariazar, Zahra
AU  - Jafariazar Z
AD  - Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, 
      Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
FAU - Afshar, Minoo
AU  - Afshar M
AUID- ORCID: 0000-0002-7209-9893
AD  - Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, 
      Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210621
PL  - England
TA  - Cutan Ocul Toxicol
JT  - Cutaneous and ocular toxicology
JID - 101266892
RN  - 0 (Hydrogels)
RN  - 0 (Placebos)
RN  - 0 (Plant Extracts)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adult
MH  - Aged
MH  - Double-Blind Method
MH  - Female
MH  - Fluorouracil/*adverse effects
MH  - Hand-Foot Syndrome/*drug therapy/etiology
MH  - Humans
MH  - Hydrogels/administration & dosage
MH  - Lawsonia Plant/*chemistry
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Placebos/administration & dosage
MH  - Plant Extracts/*administration & dosage/adverse effects
OTO - NOTNLM
OT  - 5-flourouracil
OT  - Hand-foot syndrome
OT  - Henna
OT  - Lawsone
OT  - Lawsonia inermis
OT  - capecitabine
OT  - traditional Persian medicine
EDAT- 2021/06/22 06:00
MHDA- 2022/01/18 06:00
CRDT- 2021/06/21 17:16
PHST- 2021/06/22 06:00 [pubmed]
PHST- 2022/01/18 06:00 [medline]
PHST- 2021/06/21 17:16 [entrez]
AID - 10.1080/15569527.2021.1940194 [doi]
PST - ppublish
SO  - Cutan Ocul Toxicol. 2021 Sep;40(3):257-262. doi: 10.1080/15569527.2021.1940194. 
      Epub 2021 Jun 21.