Nail psoriasis treated with Indigo naturalis in a randomized controlled clinical trial

Nail psoriasis is very difficult to treat and occurs in more than 50% of people who suffer from psoriasis.

The options for treatment are very limited as there are not any standardized therapies for nail psoriasis, however, topical steroids, vitamin A (Tazarotene) or vitamin D analog (Calcipotriol) may be used.

In Traditional Chinese Medicine Indigo naturalis hasbeen used for centuries for its antipyretic, anti-inflammatory, antiviral, antimicrobial, and detoxifying effects.

A randomized clinical trial tested Indigo naturalis for nail psoriasis with the results published in the journal Phytomedicine.

 

Here are the study details

Study design:  This study was a randomized, observer-blind, vehicle-controlled, intra-subject trial. Lindioil was applied to the fingernails of one bilateral hand (Lindioil group) and olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for 12 weeks.

Length of study:  The randomization process was conducted by block randomization method with 1:1 ratio. Beginning with week 13, Lindioil was applied to all affected nails on both hands twice daily for another 12 weeks.

Dose of study agent: All subjects were instructed to apply one drop (0.05 ml) of Lindioil or olive oil onto the nail plate folds and hyponychium of affected nails twice daily (morning and before bed). Subjects avoided washing their hands during the first 30 min after application.

Study Agent:  The powdered form of indigo naturalis used in this study was prepared from the leaves of Baphicacanthus cusia (Nees) Bremek

Lindioil was prepared using powdered indigo naturalis mixed with olive oil (1:10), Kirkland Signature Pure Olive Oil (Italian, item 71008), then heated at 120 °C for 1 h and filtered by 2-μm filter (Millipore, France). The oil extract was tested using HPLC analysis and placed in 5-ml eye drop bottles for clinical use.

 

Here are the main results

A reduction of NAPSI (Nail Psoriasis Severity Index) scores for the 12-week treatment for the Lindioil group (49.8% for one hand and 59.3% for single nail) was superior to the reduction in the scores for the control group (22.9%, 16.3%, respectively).

No Adverse events during the 24 weeks of treatment were observed.

 

Here are comments by the authors

In this study we found that a 24-week course of Lindioil resulted in a 61.0% reduction in shNAPSI scores and a 76.6% reduction in mtNAPSI scores (Fig. 3). Based on these results, the efficacy of Lindioil is comparable to that of steroids, vitamin D3 analogs, and other treatments without the associated side effects. More rigorous clinical trials are needed to make further comparisons.

and

In conclusion, we found that Lindioil was an effective and safe treatment for nail psoriasis and was acceptable to the subjects, indicating that it has great potential to become a safe and effective alternative therapy for treating nail psoriasis.

Reference

Lin et al. Efficacy and safety of Indigo naturalis extract in oil (Lindioil) in treating nail psoriasis: a randomized, observer-blind, vehicle-controlled trial.  Phytomedicine. 2014 Jun 15;21(7):1015-20.

 

Jeremy Johnson, PharmD, PhD


Categories: Clinical Trials, Detoxification, Inflammation, Skin