Submit adequate justification: CDSCO Panel tells Synokem pharma about Phase III CT of Naftifine Cream
New Delhi: Regarding the ongoing Phase III Clinical trial with the drug Naftifine HCI Cream 2%w/w, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined drug major Synokem Pharma to submit the adequate justification/rationale for the proposed un-blinding of randomization and interim analysis of data before the committee.
A 'blind' study is a clinical trial in which the subject or the Investigator (or both) are unaware of which trial product/drug the subject is taking. When only one is blinded to the data this is a 'single blind' study. When both do not know the treatment, the study is 'double-blind'. Studies in which the participant takes part in three arms, such as placebo, active drug and comparative drug remain as double blind.
Unblinding is the process by which the allocation code is broken so that the Clinical trial investigator (CI) and/or trial statistician becomes aware of the intervention.
Although the exact mechanism of action against fungi is not known, naftifine appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2,3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.
