NCT03614221

Comparison of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® Ointment 0.1% in Treating Atopic Dermatitis

Comparison of the Efficacy and Safety of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® (Tacrolimus 0.1%) Ointment in Treating Atopic Dermatitis: A Randomized, Evaluator-blind, Crossover, Active-Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aims of this study are: 1. Compare the efficacy of Lindioil ointment and Protopic® ointment in treating atopic dermatitis. 2. Compare the safety of Lindioil ointment and Protopic® ointment in treating atopic dermatitis. 3. Compare the time to relapse after ceasing of treatment of Lindioil ointment and Protopic® ointment. 4. Compare the change of skin microbiome before and after Lindioil ointment and Protopic® ointment treatment.

Detailed description

Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by itchiness. Topical corticosteroids are typically used to treat AD. However, many patients have concerns about the safety of long-term use, and seek alternative therapies such as traditional Chinese medicine (TCM). In TCM, indigo naturalis has been used to treat various infectious and inflammatory skin diseases for hundreds of years. The investigate also found that the results of indigo naturalis ointment treatment in other trial were comparable to the results of calcineurin inhibitor (such as Tacrolimus) treatment, and would like to verify this assertion. The aim of this study is to compare the efficacy of Lindioil ointment with that of Protopic® (Tacrolimus ointment 0.1%) in treating AD.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Lindioil ointment	Each gram contains 200µg of indirubin. Apply 0.5 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.
DRUG	Protopic ointment 0.1%	Each gram contains (w/w) 0.1% of tacrolimus. Apply 0.1 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.

Timeline

• Start date: 2019-06-03
• Primary completion: 2021-12-01
• Completion: 2021-12-06
• First posted: 2018-08-03
• Last updated: 2023-02-10

Locations

2 sites across 1 country: Taiwan