Foamix, a clinical stage specialty pharmaceutical company, has completed Phase II clinical trials of its Minocycline Foam 4%, a first topical minocycline product that can be used for the treatment of acne, rosacea and skin infections. The double blind, dose ranging, placebo controlled study followed 150 patients with moderate to severe acne. Patients were randomized into three equal groups of 50 patients, who received placebo, or one of two Minocycline Foams--1% or 4%.
Once daily treatment with Minocycline Foam 4% exhibited an average 71% reduction in inflammatory lesions after six weeks with a respective reduction of 55% in non-inflammatory lesions. At the end of the 12-week treatment period, the reduction in inflammatory lesions was at 72% with the reduction in non-inflammatory lesions reaching 73%. The effects were dose-dependent, as demonstrated by lower effects seen with 1% foam and placebo.
The Investigator’s Global Assessment (IGA) scores also significantly improved during the trial. At 12 weeks, 53% of the patients had an IGA score of either “Clear” or “Almost clear, ” while only 20% of the placebo-treated patients had the same scores.
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Among patients in the Minocycline 4% group, 61% stated that the efficacy was very high or high, and 27% rated the efficacy as moderate (median efficacy rating in the placebo group was “moderate”).
Adverse events included mild and transient skin dryness, peeling and/or erythema, evenly distributed among the treatment groups. No drug-related systemic adverse events were noted.
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The research revealed that the decline of autophagy activity in skin adversely affects epidermal homeostasis and disturbs formation (cornification) of the stratum corneum, which functions as a barrier and retains hydration in the skin.Antibiotic therapy for acne was linked with variations in the skin microbiota, some of which persisted and weren't necessarily healthy, a four-patient longitudinal study indicated.
=0.04) in the four participants, women age 25-35. But other bacteria increased, including a transient 5.6-fold rise in the relative abundance of
Is Minocycline An Effective Medicine To Treat Acne?
The tetracycline group of antibiotics, including doxycycline and minocycline, often serves as first-line therapy for moderate to severe acne because of these agents' anti-inflammatory and antimicrobial properties. Recent guidelines suggest restricting systemic antibiotic therapy to 3 to 4 months. However, prior respective studies have shown that the antibiotic treatment period always exceeds the recommended duration, noted Garza's group.
But also on the complete bacterial community of the skin, they wrote. Understanding the associations between antibiotics and skin microbiota may help clinicians decrease the likelihood of skin comorbidities related to microbial dysbiosis.
Recently introduced tools for studying the skin microbiome -- including the genome and metabolome -- have invigorated studies on their relation to disease and human health and illuminated the diversity of microorganisms inhabiting the skin surface, noted Tiffany Scharschmidt, MD, of University of California San Francisco, in an accompanying editorial.
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In the clinic, this interest manifests as a wide range of patient inquiries regarding the role of microorganisms in skin disease, the influence of prescribed therapies on the microbiome, and strategies or products to 'optimize' skin flora for health or cosmesis. Satisfactory answers to these questions are still forthcoming and will likely prove highly nuanced based on the complexity and contextuality of the skin-microbiota relationship, she wrote.
Clinicians should be enthusiastic about the possibility of microbial-directed or microbial-derived treatments as future weapons in our therapeutic arsenal while acknowledging that there is much we still do not understand about the influence of current therapies on the delicate symbiosis we maintain with our cutaneous microbiota, the editorialist emphasized.
In the context of a growing market of over-the counter products designed to restore the skin microbiome, we should further emphasize that there is no universally good or bad skin microbiome, she continued.
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Scharschmidt noted the tiny sample size and other limitations in the study by Garza and colleagues, but nevertheless called the findings intriguing and could explain some of the complications often seen from antibiotic therapy in acne.
For their part, Garza and colleagues characterized the study as a pilot investigation. They recruited the four patients in Maryland, who included two white women, one Asian American and one African American. They presented with inflammatory and comedonal acne on the face and reported no recent use of topical or systemic therapy for acne such as retinoids or antibiotics.
Patients were prescribed 100 mg of oral minocycline to take twice daily for 4 weeks. The skin on the forehead, cheek, and chin were sampled for 165 ribosomal RNA gene sequencing at baseline, 4 weeks after starting the antibiotic therapy, and then 1 week and 8 weeks after treatment ended.
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, acknowledged that the study was too small and too short to offer definitive conclusions. We only looked a short period of time after antibiotics, but people need to look much longer, like even a year, after somebody stops taking antibiotics, he said.
Paper, his group also noted that there was no clear, single pattern connecting changes in participants' skin microbiome to changes in acne lesions, perhaps also a consequence of the small sample size.
The use of a larger sample size and longer duration of antibiotic treatment would enable better characterization of changes in inflamed lesion count and α diversity, which may respond differently to antibiotic treatment depending on acne severity at baseline, they wrote. Longitudinal data of negative control participants receiving no antibiotic treatment, which we did not collect in the present study, would also enable more accurate characterization of the changes in skin microbiota associated with antibiotic treatment.
Oral Antibiotics: Minocycline
This study was supported in part by a Clinical Research Grant from the American Acne and Rosacea Society, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Scharschmidt disclosed relationship with the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Allergy and Infectious Diseases, Burroughs Wellcome Fund, Doris Duke Foundation and Leo Foundation, and Sanofi Regeneron.For decades we have known that one of the very best antibiotics at our disposal to treat inflammatory skin conditions, especially acne and rosacea, is minocycline. Minocycline is like all antibiotics in that it kills bacteria. However, more important than this is its anti-inflammatory effect.
Acne vulgaris and papulopustular rosacea are two clinically similar conditions that both affect the face and cause breakouts. With these types of acne, we tend to see inflamed bumps, some of them with an overlying white cap. These are called papules and pustules. Inside of these bumps, there are inflammatory white blood cells that substantially contribute to the problem with their inflammatory properties, including the release of proteins that further worsen inflammation.
Comparison Of Efficacy Of Oral Azithromycin With Oral Minocycline In The Treatment Of Acne Vulgaris
For decades, oral antibiotics (those taken as a pill by mouth) have been the antibiotic of choice to treat acne and rosacea (the National Rosacea Society explains why here). The best dermatologists have worked to be more conservative with the use of these medications because of their other potential effects on the body. Taking this into consideration, our general approach at Advanced Dermatology of the Midlands has always been to discuss plans for how to minimize exposure to oral antibiotics whenever we are prescribing them.
When treating these specific conditions with oral antibiotics, we also counsel patients on how they should reduce and attempt to stop the antibiotic in time as they improve. This helps to minimize systemic exposure and potential side effects. We also frequently use topical (applied) antibiotics. We use these instead of (or along with) oral antibiotics. This allows us to get the best effect possible for our patients with the highest level of safety. Where necessary, this combination can make it easier to stop the oral antibiotic more rapidly.
Minocycline has remained the most prescribed oral antibiotic for acne and papulopustular rosacea. Yet, up to now, we haven’t had a topical version of this medication. The exciting news is
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