General Information

Veltin gel is a combination of 1.2 percent clindamycin, and 0.025 percent tretinoin. It combines the anti-inflammatory and antibiotic effects of clindamycin and tretinoin. Tretinoin prevents the formation of comedones by stimulating keratinocyte production and reducing their cohesiveness. The bacteriostatic effect of clindamycin prevents proliferation of the microbial flora, thereby stopping production of inflammatory mediators that result in pustular lesions.

Veltin is specifically indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Mechanism of Action

Veltin gel is a combination of 1.2 percent clindamycin, and 0.025 percent tretinoin. It combines the anti-inflammatory and antibiotic effects of clindamycin and tretinoin. Tretinoin prevents the formation of comedones by stimulating keratinocyte production and reducing their cohesiveness. The bacteriostatic effect of clindamycin prevents proliferation of the microbial flora, thereby stopping production of inflammatory mediators that result in pustular lesions.

Side Effects

Adverse events associated with the use of Veltin may include, but are not limited to, the following application site reactions:

• dryness
• irritation
• exfoliation
• erythema
• pruritus
• dermatitis
• sunburn

Dosing/Administration

Veltin is supplied as a gel for topical administration. The recommended application is once daily in the evening, gently rubbing the medication to lightly cover the entire affected area. Approximately a pea sized amount will be needed for each application.

Clinical Trial Results

The FDA approval of Veltin was based on 12-week multicenter, randomized, blinded studies in subjects 12 years and older. Treatment response was defined as the percent of subjects who had a two-grade improvement from baseline to week 12 based on the Investigator Global Assessment (IGA) and a mean absolute change from baseline to week 12 in two out of three (total, inflammatory and non-inflammatory) lesion counts.

Study 1

In Study 1, 1,649 subjects were randomized to Veltin Gel, Clindamycin gel, Tretinoin gel, or placebo gel. At baseline, subjects had an average of 71 total lesions, of which the mean number of inflammatory lesions was 25.5 lesions and the mean number of non-inflammatory lesions was 45.1 lesions. The majority of subjects enrolled with a baseline IGA score of 3. The results were as follows:

• Percent of patients with IGA two-grade improvement: Veltin Gel: 36.3 percent; Clindamycin Gel: 26.6 percent; Tretinoin Gel: 26.1 percent and placebo: 20.2 percent.
• percent of patients with IGA of 0 (clear) or 1 (almost clear) with a two-grade improvement: Veltin Gel: 33.2 percent; Clindamycin Gel: 24.0 percent; Tretinoin Gel: 24.0 percent and placebo: 17.8 percent.
• Mean percentage reduction in inflammatory lesions: Veltin Gel: 60.4 percent; Clindamycin Gel: 56.5 percent; Tretinoin Gel: 54.5 percent and placebo: 43.3 percent
• Mean percentage reduction in non-inflammatory lesions: Veltin Gel: 51.0 percent; Clindamycin Gel: 42.9 percent; Tretinoin Gel: 47.3 percent and placebo: 36.0 percent
• Mean percentage reduction in total lesions: Veltin Gel: 55.0 percent; Clindamycin Gel: 49.0 percent; Tretinoin Gel: 50.5 percent and placebo: 39.1 percent.

The safety and efficacy of Veltin gel was also evaluated in two additional 12-week, multi-centered, randomized, blinded, studies in patients 12 years and older. A total of 2,219 subjects with mild-to-moderate acne vulgaris were treated once daily for 12 weeks. Of the 2,219 subjects, 634 subjects were treated with Veltin gel. These studies demonstrated outcomes consistent with the initial study.