CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Lindioil ointment +1 moredrug
Likely dose
Lindioil ointment 200µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03614221
NCT03614221Phase 2Completed
CompareCT.gov

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

Chang Gung Memorial Hospital·interventional·Posted Aug 3, 2018·Updated Feb 10, 2023

In Brief

A Phase 2 clinical trial evaluating Lindioil ointment and Protopic ointment 0.1% for Atopic Dermatitis. Completed, enrolled 22 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesTaiwan
CollaboratorsMinistry of Science and Technology, Taiwan

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 3, 2018
Enrollment StartJun 3, 2019
Primary CompletionDec 1, 2021
Study CompletionDec 6, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.9 years ago

Interventions

Lindioil ointmentdrug

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.

Protopic ointment 0.1%drug

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.