The One with Powerful Efficacy
MetroGel® 1% vs. Vehicle
*In a 10-week, multicenter, randomized, investigator-blinded, active- and vehicle-controlled,
parallel comparison, 746 patients applied MetroGel® 1% or vehicle QD. LOCF (last observation carried forward)
includes all subjects who received at least 1 dose of study drug, regardless of whether they completed the entire
10-week protocol ITT (intent-to-treat) population.
MetroGel® 1% patients experienced a 71% reduction in inflammatory lesions by week 10
MetroGel® 1% QD vs. Azelaic Acid Gel 15% BID
† Data from a 15-week, multicenter, randomized, investigator-blinded, active-controlled, parallel group, non-inferiority
study (N=160). Patients with moderate rosacea (an investigator’s global severity score of 3 on a scale of 0 to 4), defined as
8 to 50 inflammatory lesions on the face and a maximum of 2 nodules, applied MetroGel® 1% QD (PM) or azelaic acid gel 15% BID
(AM and PM).
MetroGel® 1% QD vs. Azelaic Acid Gel 15% BID
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**Success defined as patient having an erythema score of 0 or 1
- No statistical difference in efficacy or in reduction of inflammatory lesions between MetroGel® 1% and azelaic acid gel 15% at week 15
- Erythema success rates (proportion of patients who were rated 0 or 1 on an erythema-severity scale of 0-4) at week 15: 42.7% for MetroGel® 1% vs. 42.3% for azelaic acid gel 15% (no statistical difference)
- In this study, tolerability assessment including stinging or burning, dryness, scaling and itching, was based on a 0 to 3 scale and assessed at each visit. The worst score (worst observation of each symptom recorded for a patient during the post-baseline period) was analyzed. Safety was also evaluated through adverse event reporting
- Stinging and burning scores for azelaic acid 15% gel were statistically worse than for MetroGel® 1% at Week 3
- At Week 15, burning/stinging scores were comparable (P=.002)
- No statistical differences were found between the 2 groups for dryness and itching
- Of 131 adverse events reported by 70 patients in both arms of the study (N= 160), only 9 were treatment-related
- Adverse events reported and associated with metronidazole 1% gel treatment included conjunctivitis, abdominal pain, facial pain, hypoesthesia, rosacea flare and skin desquamation
- In patient questionnaire evaluations of tolerability, patients reported being significantly less bothered by metronidazole 1% gel treatment side effects than by azelaic acid 15% gel side effects, with 74% in the metronidazole 1% gel not being bothered at all vs. 52.7% in the azelaic acid 15% gel group (P=.009)
- Once-daily application of MetroGel® 1% achieved good efficacy and safety when compared to twice daily applications of azelaic acid 15% gel
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