Introduction
On August 26, 2013, the United States Food and Drug Administration (FDA) approved brimonidine (Mirvaso®) current gel, 0.33% * (Galderma Laboratories, Texas, USA) For the topical treatment of persistent (non-transitory) facial treatment erythema (redness) of rosacea in adults over 18 years of age.
It is the first and only FDA approved topical treatment specifically developed and indicated for persistent facial erythema in rosacea.
Evidence from clinical trials for brimonidine
The approval of the brimonidine topical gel was based on data collected from more than 550 patients included in two phase 3 clinical studies, each lasting one month. Results from both studies showed that adults using Mirvaso demonstrated significantly greater improvement in facial redness from rosacea than the vehicle gel. In addition, a long-term study was also conducted in 276 subjects who used topical brimonidine gel for up to 12 months.
Short-term studies 1 and 2
- Both studies were randomized, double-blind, vehicle-controlled clinical trials.
- The trials included 553 subjects aged 18 years and over with persistent moderate or severe rosacea facial erythema.
- Patients were treated once a day for 4 weeks with topical gel or Mirvaso vehicle.
- Overall, 99% of the subjects were Caucasian and 76% were female.
- Base severity of disease was scored using a 5-point Clinical Erythema Assessment (CEA) scale and a 5-point patient self-assessment scale (PSA), in which the subjects obtained “moderate” or “severe” scores on both scales.
- the primary effectiveness The end point in both pivotal trials was 2-degree composite success, defined as the proportion of subjects with a 2-degree improvement in CEA and PSA measured at hours 3, 6, 9, and 12 on day 29.
- In addition to day 29, efficacy was assessed on day 15 and day 1.
The key efficacy results are summarized in the table and figures below.
| Success* | Study 1 | Study 2 | ||
|---|---|---|---|---|
| Mirvaso® Topical Gel (N = 129) | Vehicle gel (N = 131) | Mirvaso® Topical Gel (N = 148) | Vehicle gel (N = 145) | |
| Hour 3 | 31% | 11% | 25% | 9% |
| Hour 6 | 30% | 10% | 25% | 9% |
| Hour 9 | 26% | 10% | 18% | 11% |
| Hour 12 | 23% | 9% | 22% | 10% |
* Improvement of 2 degrees in CEA and improvement of 2 degrees in PSA scale on day 29
Adverse reactions in studies 1 and 2
Adverse reactions reported in 330 individuals treated with topical brimonidine gel applied once daily for 29 days are summarized in the table below.
| Mirvaso® topical gel (N = 330) No. patients (%) | Vehicle gel (N = 331) No. patients (%) | |
|---|---|---|
| Erythema | 12 (4%) | 3 (1%) |
| Redness | 9 (3%) | 0 0 |
| Burning sensation on the skin | 5 (2%) | 2 (1%) |
| Dermatitis | 3 (1%) | 1 (<1%) |
| Paresthesia (tingling / prickly) | 2 (1%) | 1 (<1%) |
| Acne | 2 (1%) | 1 (<1%) |
| Blurry vision | 2 (1%) | 0 0 |
| Nasal congestion | 2 (1%) | 0 0 |
Open long-term study
- An open-label study of topical brimonidine gel when applied once daily for up to one year was conducted in individuals with persistent (non-transient) facial erythema of rosacea.
- The patients were allowed to use other rosacea therapies.
- A total of 276 subjects applied topical brimonidine gel for at least one year.
- The most common adverse events reported flushing (10%), erythema (8%), increased rosacea (5%), nasopharyngitis (5%), burning sensation on the skin (4%), increased intraocular pressure (4%) and headache (4%).
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