VELTIN SIDE EFFECTS
- Generic Name: clindamycin phosphate and tretinoin gel
- Brand Name: Veltin
- Drug Class: Acne Agents, Topical Combos
SIDE EFFECTS
Adverse Reactions In Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data reflect exposure to VELTIN Gel in 1,104 subjects with acne vulgaris. Subjects were 12 years and older and were treated once daily in the evening for 12 weeks. Adverse reactions that were reported in ≥1% of subjects treated with VELTIN Gel are presented in Table 1.
Table 1. Treatment-Related Adverse Reactions Reported by ≥1% of Subjects
| VELTIN Gel N = 1,104 n (%) |
Clindamycin Gel N = 1,091 n (%) |
Tretinoin Gel N = 1,084 n (%) |
Vehicle Gel N = 552 |
|
| 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 irritation | 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. Local Skin Reactions in Subjects Treated With VELTIN Gel
| VELTIN Gel | Vehicle Gel | |||
| Local Reaction | Baseline N = 476 (%) |
End of Treatment N = 409 (%) |
Baseline N = 219 (%) |
End of Treatment N = 209 (%) |
| 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 12 weeks of treatment, each local skin reaction peaked at Week 2 and gradually reduced thereafter.
SRC: NLM .