Novel topical complex derived from spinach shows efficacy in atopic dermatitis

A novel investigational compound derived from baby spinach leaves yielded improvements in efficacy with an attractive safety profile in adults with atopic dermatitis, according to a study.

“Atopic dermatitis is a common skin disorder for which there remains an unmet need for topical pharmacotherapies that are safe and effective,” Charles Lynde, MD, of Lynde Dermatology, Probity Medical Research, and the department of medicine at the University of Toronto, and colleagues wrote. “PUR 0110 cream (Thykamine, Devonian Health Group) is a novel investigational complex derived from organic baby spinach leaves that contains thylakoid membrane segments of various lengths that are concentrated and stabilized into a solid powder form.”

In the phase 2, multicenter, randomized, double-blind, parallel-group, vehicle-controlled study conducted at 13 sites in Canada between November 2018 and June 2020, Lynde and colleagues assessed 0.05%, 0.1% and 0.25% doses of the cream in comparison with vehicle in a cohort of 162 patients with mild to moderate AD.

There were 44 patients in the 0.05% group, 39 each in the 0.1% and 0.25% groups and 40 patients in the vehicle group.

The proportion of patients with an IGA rating of clear or almost clear served as the primary efficacy endpoint. In addition, the researchers assessed for a decrease from baseline score of at least two grades by day 29 of follow-up.

Change from baseline to day 29 in IGA was the main secondary endpoint, along with percent of body surface area (BSA) impacted, EASI score, pruritus and quality of life.

Local and systemic adverse events also underwent analysis.

The 0.1% formulation bested vehicle in terms of the primary efficacy endpoint, 30.8% vs. 6.7%, (P = .014). No such separation was reported between vehicle and the other two PUR0110 doses.

The 0.1% formulation also bested placebo in terms of change from baseline to day 29 of IGA score, BSA, pruritis and patient-reported QOL, according to the findings. Again, the other two formulations failed to demonstrate a similar effect.

Adverse event rates ranged between 40.7% and 44.3% across treatment and vehicle groups, with most events being mild. There were two severe events in the vehicle arm and one severe event each in the three active therapy arms.

“PUR 0110 cream 0.1% demonstrated rapid improvement in signs and symptoms of atopic dermatitis,” the researchers concluded. “This observation, along with its favorable safety and tolerability profile, could make it a useful therapeutic option for the treatment of atopic dermatitis.”