NCT03724903 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Chen K, Zhu L, Hu T, Tan C, Zhang J, Zeng M, Li S, Song E
Ductal Lavage for Patients With Nonlactational Mastitis: A Single-Arm, Proof-of-Concept Trial. J Surg Res. 2019 Mar;235:440-446. doi: 10.1016/j.jss.2018.10.023. Epub 2018 Nov 19.
Hu T, Li S, Huang H, Huang H, Tan L, Chen Y, Deng H, Wu J, Zhu L, Zhang J, Su F, Chen K
Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol. BMJ Open. 2020 Oct 10;10(10):e036643. doi: 10.1136/bmjopen-2019-036643. Erratum In: BMJ Open. 2022 Aug 25;12(8):e036643corr1.

Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis: a Multicenter, Randomized, Open-labelled, Non-inferior Trial.

Clinical trial NCT03724903 - References