Efficacy of topical Lawsonia inermis L. (Henna) hydrogel in fluorouracil-induced hand-foot syndrome: a pilot randomized double-blind placebo-controlled clinical trial

Abstract

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.

Keywords:

• Lawsonia inermis
• Henna
• Lawsone
• Hand-foot syndrome
• traditional Persian medicine
• capecitabine
• 5-flourouracil

Acknowledgements

The authors sincerely thank Dr. Alamdar Ashnagar (Pasteur Institute of Iran) and Poursina Pharmaceutical Co. for donating the Lawsone standard and inactive ingredients, respectively. We also thank the patients for their participation. The presented data were abstracted from a Pharm.D. thesis of Razieh Nohajerani. No specific fund was provided by any other sources.

Author contributions

Minoo Afshar contributed in conception, design and data collection, statistical analysis, supervision and drafting of the manuscript. Razieh Mohajerani contributed in data collection, statistical analysis and drafting of the manuscript. Farhad Shahi helped in patient recruitment, clinical evaluation, and data collection and Zahra Jafariazar contributed in data collection. All authors approved the final version for submission.

Disclosure statement

No potential conflict of interest was reported by the author(s).