Atopic dermatitis research

In the past 20, years atopic dermatitis hasn’t attracted the appropriate scientific attention that it sorely needs. For the patients with this chronic condition, it’s a cause for concern that the latest nonsteroidal drugs, Protopic and Elidel, were approved for use in December 2000 and December 2001 respectively.

Recently, the condition has sparked interest in the scientific community, which resulted in a broader and deeper understanding of atopic dermatitis. The research results have been interesting and new drugs have been introduced. In December 2016, the U.S. Food and Drug Administration (FDA) approved a new topical medication, crisaborole, that is based on the chemical element boron and effective against mild-to-moderate atopic dermatitis. In March 2017, FDA also approved dupilumab, which is the first biological medicine for adult patients with moderate-to-severe forms of atopic dermatitis. Currently another biological medicine, nemolizumab, is being tested. It successfully passed the second phase of the clinical trial and may soon be available to patients.

It’s also an encouraging fact that numerous topical and systemic medications have entered the second and third phases of clinical trials. You can find some of them in the table below.

Clinical trials for atopic dermatitis drugs

Clinical trials are used to test new medication for efficacy and safety for use in patients with different medical conditions, including atopic dermatitis. Before FDA approves or rejects a new medication, the medication has to pass one preclinical and three clinical phases.

Preclinical phase: The medication is tested on animals to determine how it works and/or whether it can safely be used in humans.

First clinical phase: The medication is tested on a smaller group of healthy humans or patients with atopic dermatitis. During this multiple-months phase, researches carefully monitor and record the effects of the medication on the human body. They focus mainly on early information about the efficacy of the medication, its safety, dosing and side effects.

Second clinical phase: The medication is tested on a larger group of patients with atopic dermatitis. The researchers assess the efficacy of the medication and gather additional information on its safety. The second phase can last from 6 months to 2 years.

Third clinical phase:  In the third phase, the number of patients is again increased. The trial is placebo-controlled, double-blinded and randomised. The researchers focus mainly on the long-term efficacy and safety of the medication for the patients with atopic dermatitis.

If the medication passes all four phases of the clinical trial, FDA approves it for commercial use. Once it becomes available to all patients, the medication enters the last, fourth, phase. There, it is tested for efficacy after it has already been approved, with researchers also focusing on its rare side effects.

Table: A selection of ongoing clinical studies.
Start of trial
Country
Medication
Phase
Duration
May 2017
USA
Tralokinumab/placebo
3.
33 months
April 2017
USA, Canada
ASN002/placebo
1.
9 months
November 2016
Korea
PAC-14028 cream/placebo
3.
9 months
November 2016
USA, Canada
RVT-501 0.2% ointment/RVT-501 0.5% ointment
2.
7 months (concluded)
December 2016
Canada
DS107 cream
2.
10 months
January 2016
USA
Tradipitant/placebo
2.
20 months