How effective is Doxycycline for Folliculitis? (by duration, gender, age)

What is Doxycycline?

Doxycycline has active ingredients of doxycycline hyclate. It is used in acne. Currently, eHealthMe is studying from 59,066 Doxycycline users.

What is Folliculitis?

Folliculitis (infection of hair root) is found to be associated with 812 drugs and 1,017 conditions by eHealthMe. Currently, we are studying 9,291 people who have Folliculitis.

What are phase IV trials?

Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world, as opposed to phase I-III trials that are used under specific guidelines. As a result, rare or long-term effects of a drug can be observed in a much larger population of patients and over a much longer period of time in phase IV trials. With real-world big data and AI/ML algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public.

Why use real-world data?

New drugs have to go through a series (phase I-III) of clinical trials before they are approved by the FDA. These clinical trials have guidelines about who can participate. The guidelines ensure that only a selected set of people are chosen due to time and costs. When the drugs are approved and released in the market to a much bigger and ever-changing public, it is not uncommon for drugs to behave differently in the real world than in (phase I-III) clinical trials.

During the past 30 years, special regulatory programs are available to the FDA including Fast Track (1988, in statute 1997), Priority Review (1992), Accelerated Approval (1992), and Breakthrough Therapy designation (2012). These programs potentially contribute to the variability of the quantity and quality of evidence supporting recent drug approvals.

All these suggest an ongoing need for continued evaluation of therapeutic safety and efficacy after drug approvals. The 21st Century Cures Act, passed in 2016, places additional focus on the use of real-world data to support regulatory decision making. The FDA has started to use real-world data to monitor postmarket safety and adverse events, and payers to support value-based payment program.