AcnEase is proven safe and effective in clinical trial

Herborium has developed and will be introducing a new product line "The AcnEase Skin Management System?" (ASMS) the perfect compliment to AcnEase. ASMS will contain a line of products including: a mask containing colloidal gold for repairing acne marks and scars, a natural hypoallergenic line of topical products supporting healthy skin and a product addressing existing pimples.

Science Behind AcnEase®

AcnEase® is a proprietary all natural botanical therapeutic® specifically developed to treat skin disorders including acne. AcnEase is a blend of the highest quality herbal extracts selected for their inherent properties to overcome the medically recognized factors involved in the formation of whiteheads, blackheads and pimples.  This clinically tested product provides a necessary balance between demonstrated effectiveness and safety for individuals suffering from acne. AcnEase is gluten free, phytoestrogens free, animal by products free and chemical and GMO free.

Why It Works

AcnEase herbal ingredients work synergistically to restore the internal physiologic balance that is disrupted by endocrine changes, mental tension, stress and diet. Acne is actually a visible or external manifestation of an internal disorder. Acne is caused by an over production of sebum by the sebaceous glands in your skin.  This excess sebum tends to clog pores, which then accumulate dead skin cells and bacteria.  These clogged pores are visible on the surface of the skin as white heads, black heads (comedones) and pimples. AcnEase works to decrease this excess sebum production, thereby decreasing oily skin, and reducing the number of comedones and pimples seen on the surface of the skin. AcnEase is therefore unique in that it addresses the cause of acne and skin related problems.

Clinical Trials

AcnEase has been shown in clinical trials to successfully (95%) improve acne in patients 15-31 years of age caused by overproduction of the sex hormones (androgens or estrogen) and to reduce the inflammation caused by bacteria growing in the clogged pores of the skin. AcnEase has also been shown to be a highly effective (over 85% response rates) for adults with chronic and adult acne. This is not surprising since the same factors responsible for teenage acne cause adult acne.  Since AcnEase was developed to correct, its beneficial effect is not restricted to acne. Improvement in chronic facial flushing and GI related problems associated with chronic facial flushing (Rosacea) and acne have also been reported following treatment.

Proven Results

AcnEase has received the highest award for clinical efficacy in China, successfully improving acne in more than 95% of patients in controlled clinical studies. Today AcnEase is manufactured in the USA under current Good Manufacturing Practices (GMPs), satisfying the highest standards for manufacturing of herbal-based medicines.  Experiential data collected from thousands of customers indicates over a 96% satisfaction rate.

Depending on the severity of the symptoms, AcnEase may produce noticeable results within 1-2 weeks. To achieve general improvement in cysts, whiteheads, blackheads, or pimples, the standard 1 month of treatment must be completed. For individuals whose acne is chronic, and was resistant to standard Western medical treatment, an increased dose and duration may be necessary. Learn which treatment is right for you based upon your symptoms.  

Safety and Other Benefits

The ingredients present in AcnEase have been tested extensively at doses that greatly exceed the human dose, and have been shown to be safe with no signs of toxicity (Preclinical Safety). In addition, none of the herbal ingredients present in the AcnEase formula have been cited on the list of dangerous herbs compiled by International regulatory authorities; nor is it on their list of herbs known to cause serious side effects. The herbs used to make AcnEase are not present on the endangered species list either.

AcnEase achieves its beneficial effects by targeting the cause of acne without the harmful effects associated with the long-term use of other systemic agents.  Oral antibiotics for instance are taken to reduce the number of bacteria growing in clogged pores; they do not prevent over production of sebum.  The widespread use of antibiotics is not supported by the medical community due to the development of antibiotic resistant bacteria. Isotretinoins (Accutane) do target over secretion by sebaceous glands, but are associated with a number of serious side effects including depression in young males, birth defects, inflammatory bowel disease etc. Accutane is actually presently a subject of Class Action Suit in regards to those adverse effects and the use of its  generic versions   is reserved for the most severe forms of chronic acne and accompany by a legal release.

For mild to moderate acne, topical agents are routinely used.  Firstly, these products primarily treat existing pimples and do little to prevent new pimples from forming. The most common active ingredients present in topical products include benzoyl peroxide ) and salicylic acid; both ingredients can lead to dry, irritated and prematurely aged skin.  Many topical products, including the retinoic acid based products, cause skin irritation and also have sun restrictions for use. The common denominator for all topical products is they all treat the visible manifestation of acne, “the pimple” but do little to prevent future acne.  AcnEase is unique in that it targets the cause of acne providing longer-term results.  And given its unique mechanism of action, it can be used carefully in conjunction with topical agents.

Below please find a comparison between AcnEase®  and other acne products

Acne Products Major Effects Compared

Product All Natural Botanical Ingredients Skin Irritation, Sensitivity Or Rush Restricted Sun Exposure Safe for Stomach Safe for Pregnancy Prevents New Acne From Re-Occurring
Compare AcnEase treatment to acne product competitors(Systemic) YES NO NO YES YES YES
Retin-A (Topical) NO YES YES Topical YES NO
Tetracycline &other Antibiotics (Systemic) NO YES YES NO NO NO
Benzoyl Peroxide (BP) (Topical) NO YES YES Topical Warning NO
Differin (Adapalene) (Topical) NO YES YES Topical Warning Category C2 NO
Azelex (Topical) NO YES YES Topical Warning Category B2 NO
Salicylic Acid (Topical) NO YES YES Topical Warning NO
Accutane1 (Lsotretinoin) (Systemic) NO YES YES NO NO Class Action
Proactiv (BP & Salicylate) (Topical) NO YES YES Topical Warning NO

Information derived from the 2010 Physicians Desk Reference. Revised by Herborium Group, Inc., 2011.
1 Accutane has been reported to cause severe depression especially in young men
2 Products in categories C and B relating to pregnancy should only be used after consulting your physician

Pregnancy Categories for Drugs from the FDA

Category Definitions* Clinical Application
Category A "Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimester), and the possibility of fetal harm appears remote." For all practical purposes, there are no Category A drugs.
Category B "Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters)." Category B drugs include prenatal vitamins, acetaminophen and several other medications used routinely and safely during pregnancy. If there is a clinical need for a Category B drug, it is considered safe to use it.
Category C "Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus." Category C drugs have not been shown to be harmful to fetuses (if they had been, they wouldn't be Category C drugs). However, there are some reasons to be more concerned about these drugs than Category B drugs. If the pregnant patient will benefit from a Category C drug, it is generally used, although most obstetricians would prefer a Category B drug if it will give equivalently good results.
Category D "There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective.)" Category D drugs have some significant risks. They should be used during pregnancy only when the alternatives are worse.
Category X "Studies in animals or humans have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated for those who are or may become pregnant." Category X drugs should not be used during pregnancy

HAE01 AcnEase® : Clinical Experience Summary

AcnEase® has also been shown to be effective in older individuals with Chronic Acne, however, the response rate in these studies was lower. Since AcnEase® was developed to correct bodily imbalance its beneficial effect is not restricted to Acne. Improvement in chronic facial flushing and GI related problems associated with chronic facial flushing and Acne have also been reported following treatment.

Clinical Experience * AcnEase®

Age Groups Number Treated Responders** % Cure % Effective*** % Non-responders %
15-30 300 75 25 210 70 285 95 15 5
31-45 100 41 41 39 39 80 80 20 20
Totals 400 116 29 249 62 365 91 35 8.75

* Data summarized from Chinese NDA submission.

* * Responders are those that improved but did not show a complete recovery at the end of the first course of therapy.

*** %Effective is equal to the total number of patients cured and responders.

These results demonstrate that in adolescent Acne approximately 95% of the patients responded to AcnEase®. In people above 31 years of age the level of effectiveness dropped slightly to 80%. The overall positive response rate to AcnEase® treatment was therefore 91%.

AcnEase® Clinical Safety

Clinical Safety

Safety assessment was based upon physical examinations, abdominal ultrasound, EKG, thoracic X-ray and full clinical chemistry and hematology.  Any possible adverse events or side effects were also monitored.

All clinical chemistry and hematology tests following 30 days of treatment were found to be normal.  All physical examinations, including abdominal ultrasound, EKG’s and X-Rays were found to be in normal in all ranges following treatment.  There was no sign of allergic responses or any form of anaphylactic response.  

Pre-clinical Studies And Toxicology

Four distinct studies were performed including: a maximal tolerated dose/LD50 experiment in mice, bone marrow micro-nucleus assay for mutagenicity, Ames test, and the mouse sperm cell deformity assay. In the study on mice the used dose represented approximately 24 to 240 times the standard human dose used in AcnEase. The mice were observed for 2 weeks for all signs and symptoms of toxicity. There were no overt signs of toxicity and no recorded deaths determined for both males and females.

Ames Testing

The use of the Ames test is a standard method used to explore the mutagenic potential of test articles. The experiments are performed on the active ingredients directly and in a second test following incubation with mircrosomal enzymes.  The drugs are incubated with the liver microsomes to mimic the effect of liver metabolism on the active ingredients to insure that metabolites of the drug do not possess mutagenic potential.  The test is performed in 4 separate bacterial strains. 

The results clearly demonstrated that AcnEase is not mutagenic in the Ames Assay when tested directly or following incubation with mircrosomal enzymes.

Mice Bone Marrow Micronucleus Assay

The purpose of these experiments is to determine if AcnEase will induce chromosomal aberrations,  which is an index of mutagenicity and carcinogenicity.  50 Kunming mice (25 males and 25 females) weighing between 35-30 grams were used in this study. The results clearly demonstrated that AcnEase® treatment does not induce changes in bone marrow chromosomes supporting the position that the product is not likely to induce mutagenic are carcinogenic changes in cells.

Mice Sperm Deformity Assay

This assay is performed to determine if AcnEase will induce aberrations in germ cell lines.  The xxperiments were performed in 25 male Kunming mice 25-35 grams in weight.  The results demonstrated no statistically significant difference between the control group and any of the AcnEase tested groups.  The results confirmed that AcnEase does not adversely affect germ cell lines.  

AcnEase® Manufacturing Standards

The AcnEase® formula is protected by trade secrets and the product is manufactured in the USA in an FDA approved facility.

AcnEase® is manufactured in the USA according to GMPs (Good Manufacturing Practices). The herbs are tested extensively (see QC) before being extracted using state of the art equipment. Extracts are boiled for 1 hour 40 minutes; raw materials that are not extracted are hot air sterilized at 140°C for 3 hours. The finished products are then thin coated to minimize taste and facilitate swallowing, and packaged in temper and environment resistant bottles.

AcnEase QC Summary

QC Summary

All raw materials and final tablets are subjected to rigorous testing according to pharmacopeia`s standards.

Raw materials are visually inspected for evidence of mold, rot or any indication that the herbs are not of acceptable quality according to specific SOP's. Each extract is tested for: DDT, Benzex, Arsenic, and Lead. Microbiological testing is performed to check for Colony Forming Units, colibacillus, serratieae, shigella, golden staphylococcus, hemolytic staphylococcus, pathogenic bacteria, mold and yeast.

Tablets are routinely tested according to a predetermined regimen as  to meet the quality standards regarding purity and stability of the ingredients  and water content.  The tablets are also tested for hardness, appearance, integrity and dissolution. Stability testing for a minimum of 24 months is also performed on the commercial batches.