Rosacea
Name the major phenotypes of a mild to moderate rosacea patient?
Mild - Few papules and/or pustules; mild erythema
Moderate - pronounced number of papules and/pustules, but less than numerous papules and/or pustules; moderate erythema
Finacea Foam should be used continuously
over __ weeks?
Which competitive product contains Ivermectin 1%
Although the mechanism of action is unknown, what is the theorized mechanism of action?
1) Soolantra
2) Kill demodex mites that may contribute to rosacea. (anti-parasitic), anti-inflammatory
How many patients were involved in the clinical trials
1362
Which pregnancy category is Finacea Foam
B
Skin affected by rosacea is characterized by a lack of what?
Antioxidants
Name the components of Finacea Foam cosmetically elegant vehicle
2 emollients
humectant
Not alcohol based
Fragrance-free
Although the mechanism of action for Metrogel is unknown, what is the theorized mechanism of action?
To kill bacterial and other organisms associated with rosacea
What efficacy end points were evaluated to determine treatment success in the primary clinical trials?
1) Nominal change in inflammatory lesion count from baseline
2) A score of "clear" or "Minimal" with at least 2-step reduction from baseline on a 5-point IGA
Name 4 Adverse Reactions of Finacea Foam that are greater than or equal to .5%
Local site pain (6.2%)
Pruritus (2.5%)
Dryness (0.7%)
Erythema (6.1)
What is the typical age of the onset of rosacea?
30-50
How is Finacea Foam supplied?
50g can
What is the indication of Rhofade?
Why was Finacea Foam superior to its vehicle in the treatment of rosacea in reducing the number of inflammatory papules and pustules and demonstrating success according to IGA as well as reduction in mean lesion count at the end of the treatment?
One of the secondary features of rosacea is dryness of central skin due to trans-epidermal water loss (TEWL). The foam vehicle as a treatment component of Finacea Foam, was specifically formulated for rosacea affected skin. The foam vehicle, containing two emollients and a humectant provides an elegant and moisturizing drug delivery vehicle that in its base is void of the dryness effects of alcohol.
How many contraindications does Finacea Foam have
None
Name 4 triggers of rosacea
1. Spicy and thermally hot food/drinks
2. Alcohol
3. Stress
4. Weather
How is Finacea Foam applied?
twice daily (morning and evening) to the entire face area (cheeks, chin, forehead and nose).
For a single application, dispense the smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer. (Essentially a nickel size amount)
List the active ingredient, indication and dosing for Foamix (Pre-market asset) product for rosacea
1) Minocycline 1.5%
2) Moderate to Severe Rosacea
3) Once Daily
What was the mean age of subjects in the 2 clinical trials?
What was the mean lesion count?
1) 50.6 years old
2) 21.3
3) 12-50 lesions
Name a skin reaction that has had isolated reports after use of azelaic acid and is noted in the "warning and precautions" section of the PI
Hypopigmentation
Rosacea primarily affects what primary areas of the face?
Convex areas of the central face
What are the 2 emollients in the vehicle? What is the humectant?
2) Propylene glycol
Name an Oral therapy that is commonly used to treat rosacea?
Oracea (Doxycycline, USP 40g)
What is the IGA success rate and nominal change in inflammatory lesion count from baseline to end of the 12-week treatment period
IGA - 43.4% vs 32.5%
Nominal change in inflammatory lesion count - a reduction of 13 lesions
Name 7 pieces of patient counseling information
1. Cleanse affected area(s) with very mild soap
2. Shake well
3. Avoid use of alcohol cleaners, tinctures and astringents, abrasive and peeling agents
4. Avoid contact with eyes, mouth or mucous membrane
5. Cosmetics may be applied after application
6. Avoid use of occlusive dressings and wrappings
7. Flammable