Post-steroid management of chronic vulvar itching with a topical formula containing natural anti-itching and anti-inflammatory actives

Figures & data

Table 1 Personal and baseline characteristics of the subjects (48 per group)

Variable	Zantogin^®	Placebo
Age (years)	57.9 ± 13.9	56.2 ± 14.6
Duration of symptoms (months)	4.5 ± 1.5	4.0 ± 1.5
Scorea at t = 0 (before MF)	7.9 ± 1.8	7.6 ± 1.7
Scorea following MF	0.4 ± 0.2*	0.3 ± 0.2*

Notes: Data are presented as mean value ± standard deviation.

a According to a visual analog scale from 0 to 3 (0 = absent; 1 = mild; 2 = strong; 3 = severe); a global score was given after assessing for itching, burning, and stretching of wounds.

* P < 0.01 versus score at t = 0.

Abbreviation: MF, mometasone furoate.

Table 2 Clinical score after 60-day treatment, as evaluated in subjects who completed the study, number of subjects using MF as needed, and number of total application of MF

Group	n	Scorea at t = 60 (M ± SD)	Subjects using MF (n)	Total MF applications (n)
Zantogin^®	46	0.5 ± 0.2	7*	23*
Placebo	47	0.8 ± 0.4	42	682

Notes:

a According to a visual analog scale from 0 to 3 (0 = absent; 1 = mild; 2 = strong; 3 = severe); a global score was given after assessing for itching, burning, and stretching of wounds.

* P < 0.01 versus placebo.

Abbreviations: M, mean; MF, mometasone furoate; SD, standard deviation.

Table 3 Tolerability, side effects, and dropouts

Group	Tolerability	Dropouts	Side effects
Zantogin^®	Excellent (n = 26)	n = 2	Burning (n = 2)
	Good (n = 20)
	Very poor (n = 2)
Placebo	Excellent (n = 36)	n = 1	Burning (n = 1)
	Good (n = 10)
	Very poor (n = 1)