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.
By: BRUCE JANCIN, Family Practice News Digital Network
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.
Dr. Baldwin is on the advisory boards and/or speakers bureaus of Galderma and 10 other pharmaceutical and cosmetics companies.