Topical prebiotics/postbiotics and PRURISCORE validation in atopic dermatitis. International study of 396 patients

Figures & data

Figure 1. Itch Scale: PRURISCORE.

Table 1. Definitions of prebiotics, probiotics and postbiotics according to present international standards.

Prebiotics

According to the definition formulated in 2017 by the International Scientific Association of Probiotics and Prebiotics (ISAPP), prebiotics are ‘substrates selectively used by host microorganisms that can provide beneficial effects’. The best-known prebiotics, which have been studied for their modulating effect on the bacterial flora, are oligosaccharides, particularly inulin and fructo-oligosaccharides (FOS), found in cereals, fruit and vegetables, and galacto-oligosaccharides (GOS), normally found in breast milk, but also produced from lactose by the enzyme b-galactosidase.

Probiotics

According to the FAO/WHO (Food and Agriculture Organization/World Health Organization) definition, probiotics are ‘live microorganisms that, when administered in adequate quantities, confer a health benefit on the host’. For use in food, probiotic microorganisms should not only be able to survive passage through the digestive tract, but also have the ability to proliferate in the gut.

Postbiotics

According to the ISAAP definition, postbiotics are ‘a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host’. Postbiotics are therefore deliberately inactivated microbial cells with or without metabolites or cellular components, which contribute to proven health benefits. The site of action of postbiotics is not limited to the gut and they can be administered to a host surface such as the oral cavity, intestine, skin, urogenital tract or nasopharynx.

Table 2. Individual characteristics and treatment use at baseline (t0) of the survey population.

Total subjects (n = 396)
Characteristics	n (%)
Geographical area
Albania	83 (21.0)
Belarus	28 (7.1)
Croatia	5 (1.3)
Greece	128 (32.3)
Italy	76 (19.2)
Slovenia	7 (1.8)
Spain	62 (15.7)
Ukraine	7 (1.8)
Age
Mean age (SD)	21.0 (16.2)
Median age (interquartile range)	16.0 (25.0)
1–3 years	48 (12.1)
4–15 years	141 (35.7)
>16 years	206 (52.2)
Phase
Acute	198 (50.6)
Chronic	148 (37.9)
Remission	45 (11.5)
Previous drug and cosmetic therapies^a
No	82 (21.7)
Yes	296 (78.3)
If yes, result^a
Very good	4 (1.5)
Very good	5 (1.8)
Good	70 (25.5)
Moderate	151 (54.9)
Unchanged	45 (16.4)
Concomitant drug therapies^a
No	264 (70.0)
Yes	113 (30.0)

^aTotals do not correspond to the patient total due to some unknown or missing data.

Figure 2. Mean SCORAD scores of atopic dermatitis severity during the study; total and with respect to age^a.

Figure 3. PRURISCORE mean scores of atopic dermatitis severity during the study, total and with respect to age^a,b.

Table 3. Clinical characteristics at baseline (t0) of the investigated population.^a

Characteristics	n (%)
Scorad
<15	97 (25.2)
15–<40	256 (66.5)
≥40	32 (8.3)
Mean Scorad (SD)	24.6 (12.2)
Median Scorad (interquartile range)	22.4 (17.0)
Pruriscore
No pruritus	5 (1.3)
Barely noticeable	31 (8.1)
Annoying itching	129 (33.7)
Very uncomfortable itching	139 (36.3)
Very severe itching	62 (16.2)
Intolerable itching	17 (4.4)

Total subjects (n = 396).

^aTotals do not correspond to the patient total due to some unknown or missing data.

Table 4. Descriptive results on severity of atopic dermatitis and quality of life at different times in treated subjects.

Characteristics	n	t0	t1	t2	t3	Δt1–t0 (%)	Δt2–t0 (%)	Δt3–t0 (%)
Severity of AD
SCORAD, Mean ± SD	276	25.0 ± 12.9	16.3 ± 11.3*	12.0 ± 10.2*	10.2 ± 9.9*	−34.8%	−52.0%	−59.2%
PRURISCORE, Mean ± SD	310	2.84 ± 0.99	1.88 ± 0.92*	1.34 ± 0.94 *	1.02 ± 0.96*	−33.8%	−52.8%	−64.1%
IGA, Mean ± SD	299	a	1.89 ± 1.05	1.31 ± 1.01^b*	0.96 ± 1.08^b*	a	−30.7%^b	−49.2%^b
Quality of life
IDQoL (patients < 4 years)	28	12.3 ± 7.4	7.1 ± 5.4*	3.3 ± 3.7*	2.5 ± 3.0*	−42.3%	−73.2%	−79.7%
CDLQI (patients 4–15 years)	84	12.0 ± 6.4	6.6 ± 5.1*	3.8 ± 3.7*	2.1 ± 2.8*	−44.6%	−68.6%	−82.3%
DLQI (patients > 15 years)	144	10.0 ± 6.9	5.9 ± 5.5*	3.6 ± 4.9*	2.7 ± 4.6*	−40.7%	−63.5%	−73.3%

^aData at baseline on IGA were not available at all enrollment centers and were therefore not considered.

^bComparison versus t1.

*p-value <.001 versus t0.

Figure 4. The eyelid dermatitis of this young woman responded beautifully to the treatment.

Figure 5. This very pruritic dermatitis of the antecubital fossa was rapidly contained by the treatment.

Figure 6. This chronic perioral dermatitis in this young boy was finally controlled by the treatment.