Clindamycin Phosphate and Tretinoin Gel
Name: Clindamycin Phosphate and Tretinoin Gel
Side effects
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.
Read the entire FDA prescribing information for Veltin (Clindamycin Phosphate and Tretinoin Gel)
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