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Minocycline Topical Foam 1.5% Approved by FDA for Rosacea

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FDA approves first topical minocycline Foam 1.5% ZILXI for the treatment of inflammatory rosacea. Minocyclin is a tetracycline-class drug that was originally approved as an oral formulation for the treatment of acne vulgaris but now being developed into topical formulation to treat both acne vulgaris and rosacea. Previously on Oct 2019 same formulation in the name of Amzeeq 4% topical foam was approved for the treatment of acne.

ZILXI, developed as FMX103 by Menlo’s wholly-owned subsidiary Foamix Pharmaceuticals Ltd. (“Foamix”), is the first minocycline product of any kind to be approved by the FDA for use in rosacea.

“This approval is welcome news for clinicians and patients who seek novel options for this difficult to treat skin disorder,” said David Domzalski, Chief Executive Officer of Menlo. “ Minocycline Foam ZILXI 1.5% is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective.”

Rosacea is a diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory lesions (papules and pustules).

Minocycline is one of several broad-spectrum antibiotics known as tetracyclines with anti-inflammatory properties; their use in some patients is limited due to systemic side effects when taken orally. In ZILXI, Menlo has once more leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to effectively deliver minocycline in a foam-based vehicle.

Rosacea
Rosacea

“This is the only product containing minocycline approved by the FDA for rosacea,” said Iain Stuart, PhD, Chief Scientific Officer of Menlo. “The availability of a novel topical formulation of this molecule underscores our efforts to provide innovative treatment options for patients who suffer from difficult to treat skin conditions.”

The FDA approval of ZILXI is primarily supported by data from two clinical trials in 1,522 patients 18 years of age and older. In each 12-week multicenter, randomized, double-blind, vehicle-controlled trial, subjects with inflammatory lesions of rosacea were treated once daily with ZILXI or vehicle. No other topical or systemic medication affecting the course of inflammatory lesions of rosacea was permitted for use during these trials.

The co-primary efficacy endpoints were (a) the absolute change from baseline in inflammatory lesion counts at Week 12 and (b) the proportion of subjects with treatment success at Week 12 defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade improvement (decrease) from baseline at Week 12. ZILXI met both co-primary endpoints in each clinical trial, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success.

No treatment-related serious adverse events were reported. The most common adverse reaction reported by ?1% of subjects treated with ZILXI and more frequently than in subjects treated with vehicle was diarrhea (1% vs. 0%), respectively.

Menlo anticipates having ZILXI available for prescribing by 4th quarter of this year.

News Source:  Menlo Therapeutics

Kangaroo care for premature babies showing promising benefits for heart and brain functioning

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A world-first study led by Monash University has demonstrated significant benefits to a premature baby’s heart and brain function when held by the parent in skin-to-skin contact called kangaroo care.

Parent-infant skin-to-skin care (SSC) or kangaroo care, started in the late 1970s in Columbia when incubators to keep babies warm were not available. It is now widely recognised as a beneficial component of holistic care provided for pre-term infants.

Incorporating 40 pre-term babies born at around 30 weeks (normal is 40 weeks) and with an average weight of 1.3kg (normal is 3kg) the study, led by Professor Arvind Sehgal, Neonatologist & Head of Neonatal Cardiovascular Research at Monash Children’s Hospital and Professor of Paediatrics at Monash Health,  found that one hour a day of kangaroo care significantly improved blood flow to the brain and cardiac function, in comparison to measurements done while in the incubator.

This study, published in the Journal of Paediatrics, provides scientific evidence and rationale as to why the infant’s heart rhythm and neurodevelopment is better with regular kangaroo care. Improving blood supply is important as it carries oxygen and nutrients to the brain and other organs, and guides neurodevelopment.

Abigail Meijers

“The findings of our study are significant as this is a low cost intervention, easily applicable to infants in neonatal units across the world, and helps the most vulnerable of the populations we care for,” Professor Sehgal said.

While SSC is a common practice worldwide, barriers still remain. These include concerns that infants might get cold or small premature babies are unstable and might not tolerate this handling, leading to compromised heart function or unstable blood pressure. However in this study, infants maintained their temperature (in fact, slightly higher than baseline), when measured one hour after SSC.

Previously noted benefits of kangaroo care include reduced stress and crying, increased parent-infant bonding. It is beneficial to parents (mothers) as well as it reduces stress, and increases breast milk supply.

“SSC is perhaps the normal physiological state, while the stress response of being separated from parents is the status of the pre-term infants the vast majority of the time,” Professor Sehgal said.

“We hope this study encourages neonatal units around the world to promote kangaroo care, as well as reassure places where this is already being practised, that the effort and commitment from staff and parents is worthwhile.”

Source:

News provided by Monash University. 

Long Term Breastfeeding May Increase Risk of Eczema in Children

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While evaluating the results of several studies addressing on the effect of breastfeeding and the risk of childhood eczema, the results have been a controversy, but majority of reviews and research done on this topic reports a common conclusion that there is relationship between long term breastfeeding and risk of childhood eczema.

Recently a research published in Journal of Allergy and Clinical Immunology showed that long term breastfeeding may increases risk of eczema in children, whereas the risk of wheezy disorder was reduced during breast feeding.

To investigate further, the researchers studied data on 321 infants from the Copenhagen Study on Asthma in Childhood (COPSAC) who were born to mothers with a history of asthma.

Over the children’s first 2 years of life, mothers completed questionnaires about breastfeeding and were asked to record any episodes of wheezing in their children lasting more than 3 days. Wheezing exacerbations were defined as episodes requiring treatment with high-dose inhaled steroids or oral steroids, or leading to hospitalization.

All diagnoses of eczema in the children during the first 2 years of life were also recorded.

In addition, the researchers measured polyunsaturated fatty acids levels in the mothers’ breast milk to investigate any possible relationship with the development of wheeze and eczema in the children.

In total, 122 children were diagnosed with eczema, 262 experienced a wheezing episode, and 36 suffered a wheezy exacerbation before the age of 2 years.

After accounting for demographics, filaggrin gene variants, parental eczema, exposure to pets at home, and maternal smoking, the researchers found that, compared with non-exclusive breastfeeding, exclusive breastfeeding was significantly associated with a 33% reduced relative risk for wheezing episodes and an 84% reduced relative risk for wheezy exacerbations.

However, exclusive breastfeeding was also associated with a significant 2.09-fold increased relative risk for eczema, after adjustment.

The researchers found no significant association between the fatty acid composition of mother’s milk and the risk of eczema or wheeze in children.

Bisgaard and team conclude: “Duration of exclusive breast-feeding increased the infant’s risk of eczema, whereas the risk of wheezy disorder was diminished during breastfeeding.”

They further suggest that “ extended breastfeeding for the prevention of eczema should not be recommended to high-risk populations.”

Source: MedWire

Dr Scott Reuben Accused of Falsifying Medical Research

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It’s what NaturalNews says – The largest research fraud in medical history. Dr. Scott Reuben, a former member of Pfizer’s speakers’ bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals.

Now being reported across the mainstream media is the fact that Dr. Reuben accepted a $75,000 grant from Pfizer to study Celebrex in 2005. His research, which was published in a medical journal, has since been quoted by hundreds of other doctors and researchers as “proof” that Celebrex helped reduce pain during post-surgical recovery. There’s only one problem with all this: No patients were ever enrolled in the study!

Dr. Scott Reuben, it turns out, faked the entire study and got it published anyway.

It wasn’t the first study faked by Dr. Reuben: He also faked study data on Bextra and Vioxx drugs, reports the Wall Street Journal.

As a result of Dr. Reuben’s faked studies, the peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 “scientific” papers authored by Reuben. The Day of London reports that 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted.

After being caught fabricating research for Big Pharma, Dr. Reuben has reportedly signed a plea agreement that will require him to return $420,000 that he received from drug companies. He also faces up to a 10-year prison sentence and a $250,000 fine.

He was also fired from his job at the Baystate Medical Center in Springfield, Mass. after an internal audit there found that Dr. Reuben had been faking research data for 13 years.

Adapted from naturalnews.com

Increased Incidence Of Skin Cancer Among Asian Living In Singapore

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A Journal published at “Journal of the American Academy of dermatology” concludes that Incidence of skin cancer among peoples of singapore has increased from 1968 to 2006 and especially among older chinese.

The incidence rates of skin cancers in Caucasian populations are increasing. There is little information on skin cancer trends in Asians, who have distinctly different skin types. So this articles focus to study skin cancer incidence rates and time trends among the 3 Asian ethnic groups in Singapore.

These data of skin cancer were analyzed from the Singapore Cancer Registry from 1968 to 2006 using the Poisson regression model.

The data reports that there were 4044 reported cases of basal cell carcinoma, 2064 of squamous cell carcinoma, and 415 of melanoma. Overall skin cancer incidence rates increased from 2.9/100,000 in 1968 to 1972 to 8.4/100,000 in 1998 to 2002, declining to 7.4/100,000 in 2003 to 2006. Among older persons (?60 years), basal cell carcinoma rates increased the most, by 18.9/100,000 in Chinese, 6.0/100,000 in Malays, and 4.1/100,000 in Indians from 1968 to 1972 to 2003 to 2006. Squamous cell carcinoma rates among those aged 60 years and older increased by 2.3/100,000 in Chinese and by 1/100,000 in Malays and Indians. Melanoma rates were constant for all 3 races. Skin cancer rates among the fairer-skinned Chinese were approximately 3 times higher than in Malays and Indians, who generally have darker complexions.

Although appropriate population denominators were used, lack of data from 2007 could have affected the results for the last time period, which comprised 4 instead of 5 years.

Adapted from the article provided by Journal of the American Academy of dermatology

A Hope For Chronic Hair Pullers

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A paper published in Archives Of General Psychiatry has given a new hope for those suffering from chronic hair pulling syndrome also known as trichitillomania.

Trichotillomania is characterized by repetitive urge to pull your hair from your scalp, eyebrows or even  other areas of your body like pubic hair. It results in noticeable hair loss

A trial was carried out to To determine the efficacy and tolerability of N-acetylcysteine in adults with trichotillomania. In a small group of 50 hair pullers ( 45 women and 5 men ) given over-the-counter antioxidant called N-acetylcysteine for 12 weeks had significant reductions in trichotillomania symptoms.

The study found that N-acetylcysteine demonstrated statistically significant reductions in trichotillomania symptoms. No adverse events occurred in the N-acetylcysteine group, and N-acetylcysteine was well tolerated.

Study Finds No Association Between Streptococcus Pharyngitis And Pityriasis Rosea

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A study at Department of Dermatology and STD, Jawaharlal Institute of Postgraduate Medical Education and Research, India suggests that there is no association between streptococcus pharyngitis and pityriasis rosea.

Pityriasis rosea is self limited skin condition of uncertain etiology. The exact cause of pityriasis rosea is not known but various hypotheses have been postulated incriminating infective agents such as viruses, bacteria, spirochete and noninfective etiologies such as atopy and autoimmune causes have also been investigated.

They undertook a study to investigate the role of Streptococcus haemolyticus in the causation of pityriasis rosea and study the levels of C-reactive protein (CRP) and ASLO titer in patients with pityriasis rosea.

The study included 20 patients with pityriasis rosea attending the outpatient dermatology department at JIPMER hospital during the period from June to December 2004. Corresponding number of age- and sex-matched controls were chosen from amongst healthy individuals and patients attending skin OPD with dermatological disorders other than pityriasis rosea.

On analyzing the data collected from 20 cases of pityriasis rosea, the average age was found to be 15.3 years and ranged from 5 years to 30 years. The male to female ratio was found to be 1.5:1. The average duration of illness was 14.5 days (median) and 29.3 days (mean). CRP was negative in all the cases as well as the controls. ASLO titer was found to be raised in 2 (10%) cases, while it remained below the critical value in all the controls. On comparing the cases and controls, the raised ASLO titer in the cases was found to be not statistically significant (p = 0.147). From the throat swab culture, Streptococcus haemolyticus was isolated from only one case and none of the controls. This finding was not statistically significant (p = 0.310).

As per the findings of the present study, They arrived at conclusion that there is no association between streptococcus pharyngitis and pityriasis rosea.

Source:

Parija M, Thappa DM. Study of role of streptococcal throat infection in pityriasis rosea. Indian J Dermatol [serial online] 2008 [cited 2009 Jan 3];53:171-3. Available from: http://www.e-ijd.org/text.asp?2008/53/4/171/44787

New Study Suggest Rifampin is the most sensitive antibiotic for acne vulgaris

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In a study Researchers at Shiraz University, Department of Biology of School of Sciences, Iran found that rifampin was the most sensitive antibiotic in vitro for acne vulgaris.They suggest a combination of rifampin with other antibiotics may be more efficient in treating Acne vulgaris.They report their findings in the December 2008 issue of the Indian Journal Of Dermatology.

Acne vulgaris is one of the most common skin disorders in youth especially during the puberty which almost affect 85%-100% of peoples at sometimes during their lives.

In a study researchers collected samples from normal skin and nodulocystic and pustular skin lesions of one hundred youngsters (64 girls, 36 boys) among college students in the age range of 18-24 years old. The specimens were cultured individually on blood agar and Muller-Hinton media. The cultures were then incubated under both aerobic and anaerobic conditions for 2 to 7 days. Bacteria were identified and their resistance to common antibiotics was evaluated according to the standard procedures.

In aerobic culture of pustular and nodulocystic skin lesions, Staphylococcus aureus was present in 41% of subjects, Staphylococcus epidermidis in 53% and Micrococcus spp in 45% of subjucts. In anaerobic bacterial culture of pustular and nodulocystic skin lesions, Staphylococcus aureus was present in 39%, Propionibacterium acne in 33% and Staphylococcus epidermidis in 21% of subjects. The results of present study revealed that clindamycin and erythromycin were the least effective antibiotics for Propionibacterium acne while tetracycline was the least effective for Staphylococcus aureus in vitro . A synergic effect of benzoyl peroxide, erythromycin or clindamycin was noticed. Rifampin was the most effective antibiotic in vitro .

Their results showed that Rifampin was the most sensitive antibiotic in vitro for acne vulgaris. To achieve a better treatment, a combination of rifampin with other antibiotics may be more efficient. Researchers further suggest in vivo studies for better evaluation and treatment of acne patients with rifampin.

Journal reference:
Hassanzadeh P, Bahmani M, Mehrabani D. Bacterial resistance to antibiotics in acne vulgaris: An in vitro study. Indian J Dermatol [serial online] 2008 [cited 2008 Dec 3];53:122-4. Available from: http://www.e-ijd.org/text.asp?2008/53/3/122/43213

Adapted from material provided by:Indian Journal Of Dermatology

Activated protein C can stimulate wound healing in patients with skin ulcers

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Current research suggest that Activated protein C can stimulate wound healing in patients with skin ulcers that are refractory to conventional wound-healing therapies,according to the article published in november issue of Archives of Dermatology.

The treatment of skin ulcers frequently presents a management challenge. Nonhealing wounds with poor response to conventional wound management therapy represent a significant cause of disability, affecting approximately 1% of the global population. Activated protein C is a serine protease with anticoagulant, angiogenic, and anti-inflammatory properties that has shown efficacy in patients for the treatment of severe sepsis. We report 4 cases of nonhealing lower limb skin ulcers that were treated with activated protein C.

The study included 4 patients whose wounds were not improving despite standard wound treatment for 4 months or more. Activated protein C was applied topically to their wounds once weekly for 4 weeks. All 4 patients showed a rapid positive response to treatment that was maintained during a 4-month follow-up period. The treatment was well tolerated, with no remarkable adverse effects or complications.

The likely mechanism of action is its recognized ability to stimulate angiogenesis and reepithelialization and to inhibit inflammation. Activated protein C has potential as a therapeutic option for patients with chronic skin ulcers.

Adapted from materials provided by Archives of Dermatology

Indigo Ointment May Help Treat Patients With Psoriasis

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An ointment made from indigo naturalis, a dark blue plant-based powder used in traditional Chinese medicine, appears effective in treating plaque-type psoriasis, according to a report in the November issue of Archives of Dermatology, one of the JAMA/Archives journals.

Psoriasis is a chronic skin disease for which no cure exists, only therapies that bring it into remission, according to background information in the article. “Traditional Chinese medicine is one of the most frequently chosen alternative therapies in China and Taiwan, and psoriasis has been treated for centuries with topical and oral herbal preparations,” the authors write. “Indigo naturalis is one of the Chinese herbal remedies that has been reported to exhibit potential antipsoriatic efficacy. However, long-term systemic use has been occasionally associated with irritation of the gastrointestinal tract and adverse hepatic [liver] effects.”

Yin-Ku Lin, M.D., of Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan, and colleagues conducted a randomized trial of an ointment containing indigo naturalis in 42 patients with treatment-resistant psoriasis. Participants enrolled in the study between May 2004 and April 2005 and applied the indigo naturalis ointment to a psoriatic plaque on one side of their body (usually on the arm, elbow, leg or knee) and then a non-medicated ointment to a parallel plaque on the other side of their body. The researchers assessed and photographed patients’ skin plaques at the beginning of the study and again after two, four, six, eight, 10 and 12 weeks.

After 12 weeks of treatment, the plaques treated with indigo naturalis ointment showed significant improvement in scaling, erythema (redness) and induration (hardening) when compared with the plaques treated with non-medicated ointment. “Weighting the sum of scaling, erythema and induration scores by the lesion area and comparing between the start and end of the study, the indigo naturalis ointment–treated lesions showed an 81 percent improvement, whereas the vehicle [non-medicated] ointment–treated lesions showed a 26 percent improvement,” the authors write.

Of the 34 patients who completed the study, none experienced worsening psoriasis in the areas treated with indigo naturalis, while the treated plaques were completely or nearly completely cleared for 25 of them (74 percent). None experienced serious adverse effects. Four patients reported itching after applying the indigo naturalis ointment, but only for a couple of days at the start of treatment.

“In conclusion, we present a randomized controlled trial showing the use of topical indigo naturalis ointment for the treatment of chronic plaque psoriasis to be both safe and effective,” the authors write. “Future research for a more potent extraction from this crude herb that can provide better absorption and convenience would help improve patient compliance with the treatment regimen. However, much more research will be necessary to clarify the pharmacology of indigo naturalis.”

This study was supported by a grant from Chang Gung Memorial Hospital.

Adapted from materials provided by JAMA and Archives Journals
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