Table 1.

Incidence and risk difference of select dermatologic adverse events of interest and diarrhea in the first 8 weeks of treatment for Cohorts I and II (evaluable population)

Incidence	SDAEIa, all grade, n (%) (95%?CI)	SDAEI, grade ≥2, n (%) (95%?CI)	Diarrhea, all grade, n (%) (95%?CI)	Diarrhea, grade ≥2, n (%) (95%?CI)
Placebo (Cohort I; n = 58)	46 (79.3) (66.6, 88.8)	27 (46.6) (33.3, 60.1)	49 (84.5) (72.6, 92.7)	24 (41.4) (28.6, 55.1)
Doxycycline (Cohort I; n = 56)	42 (75.0) (61.6, 85.6)	13 (23.2) (13.0–36.4)	46 (82.1) (69.6, 91.1)	19 (33.9) (21.8, 47.8)
Alclometasone + probiotic (Cohort II; n = 59)	47 (79.7) (67.2, 89.0)	21 (35.6) (23.6, 49.1)	49 (83.1) (71.0, 91.6)	23 (39.0) (26.5, 52.6)
Risk difference	SDAEI, all grade (90% CI)	SDAEI, grade ≥2 (90% CI)	Diarrhea, all grade (90% CI)	Diarrhea, grade ≥ 2 (90% CI)
Doxycycline versus placebo (Cohort I)	−4.31 (−18.99, 10.37); P = 0.745	−23.34 (−39.31, −7.36); P = 0.016	−2.34 (−15.58, 10.90); P = 0.933	−7.45 (−24.09, 9.19); P = 0.530
Alclometasone + probiotic (Cohort II) versus placebo (Cohort I)	0.35 (−13.64, 14.34); P = 1.000	−10.96 (−27.54, 5.62); P = 0.309	−1.43 (−14.35, 11.49); P = 1.000	−2.40 (−19.01, 14.22); P = 0.940
Alclometasone + probiotic (Cohort II) versus doxycycline (Cohort I)	4.66 (−9.92, 19.24); P = 0.708	12.38 (−3.19, 27.95); P = 0.211	0.91 (−12.47, 14.29); P = 1.000	5.05 (−11.43, 21.54); P = 0.712

^aSDAEI defined as dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin laceration, skin infection, and skin ulcer.

Confidence intervals for incidences are exact. Confidence intervals for risk differences and P values are based on the Wald asymptotic test with continuity correction.

SDAEI, select dermatologic adverse events of interest; CI, confidence interval.