Atopic dermatitis in children and adults can improve with the treatment of a solution containing Roseomonas mucosa, which decreases the severity of the disease and reduces the rate of Staphylococcus aureus colonization in children, according to findings from a phase 1 and 2 trial.
“Living with atopic dermatitis can be physically and emotionally challenging. While treatment can help manage the symptoms, currently available therapies can be time-consuming — requiring multiple daily applications — and costly,” Anthony S. Fauci, MD, director of the NIH National Institute of Allergy and Infectious Diseases (NIAID), said in a press release. “New, inexpensive therapies that require less frequent application are needed to expand the options available for atopic dermatitis treatment.”
To assess whether making changes to the skin microbiome would improve atopic dermatitis in patients, and to examine the different bacterial metabolites and topical exposures that cause imbalances in the skin of patients with the condition, the researchers conducted open-label phase 1 and 2 studies and an activity trial. The Beginning Assessment of Cutaneous Treatment Efficacy for Roseomonas in Atopic Dermatitis Trial (BACTERiA D 1 and 2) first included 10 adults and then five pediatric patients.
In the trial, patients were instructed to apply sucrose solutions that included increasing doses of live R. mucosa twice weekly. The solutions were applied topically to affected areas for 6 weeks. Following treatment, a 4-week washout phase was completed by patients. According to the researchers, the patients were administered an adequate amount of solution to apply to bilateral antecubital fossae and one additional body surface chosen by the patient.
The researchers also calculated the severity of atopic dermatitis on all participants using the SCORAD scale. Those participating in the trials did not have gram-negative bacteria present in cultures collected from their antecubital fossae.
Of the adult participants, all reported complete compliance. Solicited events, including fever (temperature of 100.4°F or greater), pain or tenderness (minimal even if not interfering with activity) and slight discoloration where the treatment was applied were reported using a memory aide or remote visits completed through text, phone or email. The researchers observed no adverse events.
When treated with the R. mucosa solution, a significant decrease in objective intensity of atopic dermatitis was observed in addition to subjective regional pruritus and antecubital-specific SCORAD; however, when the washout phase was completed, the researchers clearly observed steroid-sparing effects related to treatment with R. mucosa.
After observing the effects of treatment in adults, the researchers then enrolled five patients between the ages of 9 and 14 years. After 16 weeks of twice-daily treatments for all affected areas, no solicited or adverse events were reported in this cohort. Full compliance was reported by the parents of these children.
In these participants, the researchers also assessed for a SCORAD worsening of more than 20% in the effected area and the worsening of itching by greater than 20%. No adverse changes were observed in these outcomes after lab results were examined for complete blood counts with differential, chemistry panel, hepatic enzymes, mineral panel and erythrocyte sedimentation rate and C-reactive protein.
Furthermore, the researchers observed significant drops in SCORAD, pruritus, steroid use and improvements in areas other than the antecubital region in pediatric patients treated with the solution. When examined, all children were colonized with S. aureus before treatment. After the treatment was used on these patients, the researchers observed a decreased burden of S. aureus cultures and a decrease of the amount of the bacteria found relative to coagulase-negative staphylococci in the antecubital and popliteal fossae.
“By applying bacteria from a healthy source to the skin of people with atopic dermatitis, we aim to alter the skin microbiome in a way that will relieve symptoms and free people from the burden of constant treatment,” Ian Myles, MD, from the NIAID, said in the release. “If future clinical studies demonstrate that this strategy is effective, we hope our work will lead to the development of new, low-cost atopic dermatitis therapies that do not require daily application.” – by Katherine Bortz
Disclosures: The authors report no relevant financial disclosures.