LIVE BLOG: Treatment of Inflammatory Dermatoses & Bridging the Barriers of Acne Treatment [Product Theater: Promius]
In this live blog, Dr. Leon Kircik, presents a Promius Product Theater on Treatment of Infllammatory Dermatoses & Bridging the Barriers of Acne Treatment. Dr. Kircik reviews two well-known products: Cloderm and Tretinoin.
Cloderm has been around for a long time (apps 40 years), and has many uses. There is no age restriction: infants to elderly, Cloderm is fine. It is indicated for the relief of inflammatory and pruritic manifestations of corticostosteroid-responsive dermatoses.
1. Potency: Midstrength class 4 topical steroid.
2. Let’s talk organic chemistry: The Clocortolone pivalate structure is extremely unique in design.
3. There are 5 different types of Allergy groups for topical steroids.
Allergy groups are an “under-discussed issue.”
e.g. When you have atopic dermatitis the steroids should work. Why don’t they? They patient is likely allergic to the topical steroids. This becomes a problem for diagnosis.
Allergenicity Classification: 5 Groups
A – Higher Allergenicity
B – Higher Allergenicity
D1 – Lower Allergenicity
D2 – Higher Allergenicity
C – The only class that has none to very very low allergenicity
The only two steroids in this class are: Clocortolone Pivalate (Cloderm) & Desoximetasone)
Why is this the case? The unique design of the clocortolone pivalate.
Ingredients: the vehicle is very important, because it makes or breaks the molecule. In this vehicle there is no propylene glycole (which is very common, but very allergenic). Fragrance and lanolin free! It is a nice cream. It is emollient without being greasy.
Cloderm Cream Clinical Trials:
+ These are ancient studies, because this has been around for so long.
+ Early onset action, Day 4, shows patient doing well.
The delivery system is new, while Isotretinoin is not at all new. It’s so hard to prescribe it…it’s probably easier to prescribe Oxycontin in this country! Isotretinoin is indicated for severe acne.
Fact: Acne vulgaris affects 60-70% of Americans at some time in their lives.
Fact: 20% have severe acne with permanent physical scarring
Zenatane is generic Isotretinon; coming in the same doses as Accutane.
How are Generics approved in this country?
They have to prove to be “bio-equalent” to the reference drug. It must
Bioequivalency data: 20% below/above your reference; 90% confidence intervals.
Prescribing: The Process isn’t Easy
1. Go through the iPledge process:
2. Confirm pregnancy potential.
3. Contraception counseling/referral
4. Pregnancy Testing
5. Blood-donation Counseling
This can be a time-consuming process that must be repeated if the patient is noncompliant.
Why the iPledge program? It grew from a risk-mitigation program that grew into the full-blown iPledge.
408,000+ prescriptions were denied to failures to comply with iPledge milestones. 39% Males were denied (mostly due to prescriber not confirming patient counseling); 59% Females denied for childbearing potential.
What is “The Promius Promise”
To make the drug more accessible, and make it easier for prescribing.
How this works:
1. Unique pharmacy and concierge service from Promius available at no cost to all iPledge enrolled patients prescribed Promius meds.
2. Overnight shipping helps ensure patient obtained drug within 7-day prescription window.
3. Live US-based call center staffed Monday to Friday 8Am – 11PM EST.
4. Timely reminders via phone, email or texts if requested by patient.
5. $0 copay for eligible patients applied automatically when prescription is received.
Managed care and pharmacy issues can break the chain between provider and patient.
[image by visualpanic]