Efficacy of a topical formulation of henna (Lawsonia inermis L.) in contact dermatitis in patients using prosthesis: A double-blind randomized placebo-controlled clinical trial

Abstract

Background: Contact dermatitis is a common complication in prosthetic limb users. There are no effective, available and cheap treatments for skin problems of these patients. In traditional Iranian medicine, henna (Lawsonia inermis L.) is a plant that has anti-inflammatory, antimicrobial and skin-enhancing properties, all of which are beneficial for people with artificial limbs. The aim of this study was to assess the efficacy of a topical henna preparation in management of contact dermatitis in patients using lower limb prosthetics.

Methods: The current randomized, double-blind, placebo-controlled clinical trial was conducted on ninety-five participants with lower extremity amputation using limb prosthetics, aged 12-70 years who complained of contact dermatitis. They were randomly assigned to receive either two weeks of topical henna preparation every night as the intervention group, or topical placebo as the control group. Participants were instructed to spread henna preparation on the surfaces of the amputated limb that were in contact with the prosthesis. Severity of contact dermatitis symptoms was set as the primary outcome measure. Edema, papules and erythema were evaluated by a physician using standard color atlas. Secondary outcomes included symptoms such as burning, itching, pain, thickness and skin sweating evaluated by a self-administered questionnaire.

Results: A significant improvement was observed in the symptoms of contact dermatitis including skin edema, itching, sweating, skin thinning and pain (p-value<0.05) in the henna group compared to the placebo group. Skin burning decreased more in the henna group compared to the placebo group, but this was not statistically significant (p-value = 0.052). Moreover, skin redness significantly increased in the henna group (p-value = 0.001).

Conclusion: Topical formulation of henna might be a complementary choice for improving contact dermatitis in patients using lower limb prosthetics.

Keywords: Contact dermatitis; Henna; Lawsonia inermis L.; Prosthesis; Traditional medicine.