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

NCT03614221 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-02-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ministry of Science and Technology, Taiwan

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Yin-Ku Lin, MD., PhD. · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2021-12-01
Completion
2021-12-06

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03614221 on ClinicalTrials.gov