Topical Ivermectin may soon be used for treatment of Facial and Ocular Rosacea - Rosacea Knowledge Forum by Geoffrey Nase PhD

Dr. Geoffrey Nase · #1 (**permalink**) 17th September 2010, 03:50 PM

I've been following the development and testing of topical Ivermectin for the treatment of head lice in children. It is extremely effective and safe (it does not irritate the skin or enter the blood stream).

After discussions with several members of the TOPAZ Research and Development Team, it looks like their formulation is ideal for use on the facial skin and eyelids (for demodex-induced blepharitis and swollen eyelids). They would obviously have to do more testing, but it is a much better option than topical Permetherin Cream which is a strong irritant.

Current Studies now entering Phase III:

Topaz Pharmaceuticals Announces Positive Data from Topical Ivermectin Trials Presented at Society of Pediatric Dermatology

HORSHAM, Pa., July 28 /PRNewswire/ -- Topaz Pharmaceuticals Inc., a privately held biotechnology company, announced positive results of studies of topical ivermectin cream, which it is developing as a potential treatment of Pediculus humanus capitis (head lice).

In a Phase 2 dose-ranging study presented at the annual meeting of the Society for Pediatric Dermatology in Portland, OR, this novel topical formulation produced a statistically significant eradication of live lice as compared to vehicle. The results from another study presented at the meeting indicated that there was minimal plasma absorption of ivermectin when the topical formulation was applied to children as young as six months.

"Our foremost goal at Topaz is the successful development of topical ivermectin as a convenient application for the treatment of head lice infestations," said Thomas Beck, MD, Chief Medical Officer of Topaz Pharmaceuticals. "These results further support our belief that our topical ivermectin formulation has the potential to become an important treatment option. We anticipate concluding Phase 3 trials imminently and then to quickly progress to file a new drug application with the U.S. Food and Drug Administration."

Terri Meinking, PhD, President of Global Health Associates of Miami, Inc., presented a poster describing a dose determination study to establish the optimum concentration of ivermectin. The poster described a randomized, double-blind, dose-response study of 74 evaluable patients who received treatment with 0.15%, 0.25%, or 0.5% ivermectin, or vehicle. All ivermectin concentrations (n=51) produced a statistically significant eradication of live lice at Day 15 compared to vehicle (p less than or equal to 0.003), with 0.5%, the concentration now in Phase 3 studies, having the greatest efficacy of the three concentrations studied.

"The results from this phase 2 study are very encouraging," said Dr. Meinking. "Head lice can cause families tremendous anxiety and embarrassment, and parents are looking for a treatment that is safe and effective. Ivermectin has a well-established record in treating other parasitic infections and this easy-to-use formulation shows great promise for treating head lice."

Lydie Hazan, MD, founder and CEO of Impact Clinical Trials, presented two studies in which the pharmacokinetics, safety and effectiveness of this 0.5% ivermectin cream were assessed in head lice-infested children. Across the studies, children aged 6 months to 10 years were enrolled, including those weighing less than 15kg. Ivermectin was not detected in the plasma of any of the 10 children in the first study who were sampled. In the second study, using a very sensitive test, detected levels of ivermectin were less than 1% of those that occur when the tablet form of ivermectin is administered. In both studies, there was a high level of elimination of head lice infestations in children treated with the 0.5% topical ivermectin formulation.

Admin · #2 (**permalink**) 21st September 2010, 07:34 AM

Quote:

Originally Posted by Dr. Geoffrey Nase

I've been following the development and testing of topical Ivermectin for the treatment of head lice in children. It is extremely effective and safe (it does not irritate the skin or enter the blood stream).

After discussions with several members of the TOPAZ Research and Development Team, it looks like their formulation is ideal for use on the facial skin and eyelids (for demodex-induced blepharitis and swollen eyelids). They would obviously have to do more testing, but it is a much better option than topical Permetherin Cream which is a strong irritant.

Current Studies now entering Phase III:

Topaz Pharmaceuticals Announces Positive Data from Topical Ivermectin Trials Presented at Society of Pediatric Dermatology

HORSHAM, Pa., July 28 /PRNewswire/ -- Topaz Pharmaceuticals Inc., a privately held biotechnology company, announced positive results of studies of topical ivermectin cream, which it is developing as a potential treatment of Pediculus humanus capitis (head lice).

In a Phase 2 dose-ranging study presented at the annual meeting of the Society for Pediatric Dermatology in Portland, OR, this novel topical formulation produced a statistically significant eradication of live lice as compared to vehicle. The results from another study presented at the meeting indicated that there was minimal plasma absorption of ivermectin when the topical formulation was applied to children as young as six months.

"Our foremost goal at Topaz is the successful development of topical ivermectin as a convenient application for the treatment of head lice infestations," said Thomas Beck, MD, Chief Medical Officer of Topaz Pharmaceuticals. "These results further support our belief that our topical ivermectin formulation has the potential to become an important treatment option. We anticipate concluding Phase 3 trials imminently and then to quickly progress to file a new drug application with the U.S. Food and Drug Administration."

Terri Meinking, PhD, President of Global Health Associates of Miami, Inc., presented a poster describing a dose determination study to establish the optimum concentration of ivermectin. The poster described a randomized, double-blind, dose-response study of 74 evaluable patients who received treatment with 0.15%, 0.25%, or 0.5% ivermectin, or vehicle. All ivermectin concentrations (n=51) produced a statistically significant eradication of live lice at Day 15 compared to vehicle (p less than or equal to 0.003), with 0.5%, the concentration now in Phase 3 studies, having the greatest efficacy of the three concentrations studied.

"The results from this phase 2 study are very encouraging," said Dr. Meinking. "Head lice can cause families tremendous anxiety and embarrassment, and parents are looking for a treatment that is safe and effective. Ivermectin has a well-established record in treating other parasitic infections and this easy-to-use formulation shows great promise for treating head lice."

Lydie Hazan, MD, founder and CEO of Impact Clinical Trials, presented two studies in which the pharmacokinetics, safety and effectiveness of this 0.5% ivermectin cream were assessed in head lice-infested children. Across the studies, children aged 6 months to 10 years were enrolled, including those weighing less than 15kg. Ivermectin was not detected in the plasma of any of the 10 children in the first study who were sampled. In the second study, using a very sensitive test, detected levels of ivermectin were less than 1% of those that occur when the tablet form of ivermectin is administered. In both studies, there was a high level of elimination of head lice infestations in children treated with the 0.5% topical ivermectin formulation.

Hey Doc,

Do you still think Oral Ivermectin is the best treatment for anyone who is unsure about demodex involvement.

I'd like to see the video clip of Susan Merenstein. Please forward that to us when it is available.

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