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

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.

Timeline

Start

2019-06-03

Primary completion

2021-12-01

Completion

2021-12-06

Outcome

Missed primary endpoint

paper The BSA percentage change was significantly less in the tacrolimus group (-43.6% vs. -86.7%, P = 0.002). PMID 40697652 ↗

paper Significant differences between the 2 groups were observed in NRS (-2.5 vs. -5.5, P = 0.005) PMID 40697652 ↗

paper DLQI median change (-5 vs. -10, P = 0.005). PMID 40697652 ↗

Publications

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Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lindioil	Traditional medicine (herbal / TCM)	0.5 g	Topical
Subject	Protopic ointment 0.1%	Unknown	0.1 g	Topical

Indications