The clinical trial data for Galderma’s upcoming 1% Ivermectin Cream product (known during development as CD5024) is looking quite good.
The data is showing that Ivermectin Cream is able to effectively reduce the papules and pustules of rosacea. There may even be some hints that it has a lower adverse reaction rate compared to its competition, namely Metrogel and Finacea.
The how and why of Ivermectin topically being able to offer good results remains a mystery.
I look forward to seeing more results published for CD5024 and watching it wind its way through FDA approval.
I also look forward to more research into why Ivermectin seems to work so well!
Here are some quotes from Dr. Hilary Baldwin.
Novel topical rosacea drug sails through phase III
By: BRUCE JANCIN, Family Practice News Digital Network
02/19/14
WAIKOLOA, HAWAII – Ivermectin 1% cream for the treatment of papulopustular rosacea convincingly hit all of its primary efficacy and safety endpoints in two pivotal phase III clinical trials.
…
Roughly 40% of topical ivermectin–treated patients met the clear or almost-clear treatment success standard, a rate two- to fourfold greater than in controls in the two trials. The difference between the active treatment group and controls became statistically significant as early as week 4.
Stepping back from these compelling clinical trial data, Dr. Baldwin observed that the exact mechanism of benefit for topical invermectin in PPR has yet to be determined.
The medication is certainly acaricidal and is known to kill the demodex mites that reside in the pilosebaceous units of patients with PPR.
But it’s tough to think of demodex mites as causative in rosacea because they are also present in the pilosebaceous units of individuals without rosacea.
The latest thinking regarding the pathogenesis of rosacea is that this common chronic inflammatory skin disease is not caused by demodex mites, Propionibacterium acnes, or any other pathogen, she explained.
In the current concept, cathelicidin proteins that are present in the epidermis as part of the vanguard of the innate immune system play a key role.
When these proteins detect a foreign invader on the skin – bacterial, viral, or fungal – they release toxic enzymes, including cathelicidin LL-37, which kill the offending organism.
High levels of LL-37 are proinflammatory, angiogenic, and activate the acquired immune system, effects that would explain the chronic skin redness and telangiectasias of rosacea.
The trouble is, demodex is not a foreign invader.
“The innate immune system is not supposed to be triggered by demodex or P. acnes. They’re supposed to be in the follicle. They live there,” Dr. Baldwin said.
Why the innate immune system of patients with PPR is apparently alerted by demodex, part of the normal fauna, requires further study, she added.
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Dr. Baldwin is on the advisory boards and/or speakers bureaus of Galderma and 10 other pharmaceutical and cosmetics companies.
Related Articles
- More Proof that CD5024 is Ivermectin
- Topical Ivermectin Patent for Rosacea
- Topical Ivermectin + Metrogel from Galderma
- CD5024 Cream in Phase 3 Trials (Ivermectin 1%)
Sklice, Topical Ivermectin 0.5% for Head Lice on Scalp and Hair
buenos dias. soy de argetina y tengo rosasea tipo4. como puedo conseguir este medicamento??. muchas gracias
In my opinion the title of this article is somewhat misleading – it is quite clearly understood that ivermectin works by killing demodex mites. While Dr Baldwin disputes that demodex are the root cause, I cannot see any suggestion of her disputing that the medication works by eradicating them.
The fact that, as expected, the medication worked superbly for some patients while not working at all for others surely supports the idea that different causes/conditions are involved. Eradicating demodex works IN CERTAIN CASES. I doubt that those patients are too concerned about established whether the mites are the chicken or the egg…..
Typical beaurocratic bull, if it works than release it and work on tweeking it for everyone. If your not going to release it than don’t print that you’ve found something that works. Pissing me off
okay fyi ivermectin is used in the treatment of the red mange, in dogs. Started administering and my min pin started to die, took him to another veterinarian, he stopped the ivermectin , told me if he survives he does. but this is kiiling him , i had him for 12 years … no med