New FDA approval for Rosacea (Chronic skin disease)

ABOUT DISEASE:
Rosacea is a challenging condition to manage as it is tends to vary from patient to patient often requiring a tailored approach (by using TDM). Rosacea is a common chronic skin disease condition affecting predominantly woman(ACED 30) in US. The symptoms are inflammatory lesions,bumbs and pimples.

Causes:
The main cause of Rosacea is unknown, but researches suggest multiple triggers including exposure to sun, alcohol, spicy food & exposure.

Rosacea rashes

ABOUT DRUG:

1. Ivermectin:
USFDA approves 1% Ivermectin cream (Soolantra, Galderma Labs) for the treatment of inflammatory lesions, bumbs and pimples of Rosacea. While some Rosacea treatments for the commom bumps and pimples may take more than 4 weeks to show effect but Ivermectin cream may provides initial results as early as (with in 2 weeks).

2. Significance of drug:
The API of Ivermectin has Anti- inflammatory and anti-parasitic activity.

3. Frequency:
The ointment has to apply once-daily on lesions.

4. Clinical evidence:
Two pivotal phase 3 randomized, double blind, 12 week, vehicle- controlled studies involving 910 patients with Rosacea.

5. Safety of Ivermectin:
It is safe & well tolerated at long term use(12 weeks) although some patients reported skin burning & skin irritations.