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Adverse Reactions in Clinical Studies

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

The safety data reflect exposure to VELTIN (clindamycin phosphate and tretinoin gel) Gel in 1,104 patients with acne vulgaris. Patients were 12 years or older and were treated once daily in the evening for 12 weeks. Adverse reactions that were reported in ≥ 1% of patients treated with VELTIN (clindamycin phosphate and tretinoin gel) Gel are presented in Table 1.

Table 1: Treatment-Related Adverse Reactions Reported by ≥ 1% of Subjects

  VELTIN (clindamycin phosphate and tretinoin gel) Gel
N=1104
n (%)
ClindamycinGel
N=1091
n (%)
TretinoinGel
N=1084
n(%)
VehicleGel
N=552
n (%)
Patients with at least one adverse reaction 140(13) 38(3) 141 (13) 17(3)
Application site dryness 64(6) 12(1) 62(6) 3(1)
Application site irritation 50(5) 4( < 1) 57(5) 5(1)
Application site exfoliation 50(5) 2( < 1) 56(5) 2( < 1)
Application site erythema 40(4) 6(1) 39(4) 3(1)
Application site pruritus 26(2) 7(1) 23(2) 6(1)
Sunburn 11(1) 6(1) 7(1) 3(1)
Application site dermatitis 6(1) 0(0) 8(1) 1( < 1)

Local skin reactions actively assessed at baseline and end of treatment with a score > 0 are presented in Table 2.

Table 2: VELTIN (clindamycin phosphate and tretinoin gel) GEL-Treated Patients with Local Skin Reactions

  VELTIN GEL VEHICLE GEL
Local Reaction Baseline
N=476
N(%)
End of Treatment
N=409
N(%)
Baseline
N=219
N(%)
End of Treatment
N=209
N(%)
Erythema 24% 21% 31% 35%
Scaling 8% 19% 14% 12%
Dryness 11% 22% 18% 13%
Burning 8% 13% 8% 4%
Itching 17% 15% 22% 14%

During the twelve weeks of treatment, each local skin reaction peaked at week 2 and gradually reduced thereafter.