Study of the Safety of PM Eczederm Rescue for cases of eczema: A double-blind, randomized, placebo controlled study
Mark J. McNamara, Steven R. Frank, Breeana K. Saffell, Rosia Warner, and Gary B. Clark MD
Abstract:
Background: Eczema, an inflammatory condition of the skin, affects over 15 million Americans a year. Standard medical care includes the use of topical steroidal creams, avoidance of known allergens, and the administration of immuno-modulators in severe cases. The present study examines the safety of a topical, herbal cream for cases of mild to moderate eczema.
Methods: Subjects were consented, enrolled, and followed for a total of 4 weeks. During weeks 2 and 3, subjects applied either Peaceful Mountain Eczederm Rescue or a placebo three times a day. Subjects recorded on a daily basis the side effects experienced.
Results: Both groups reported some side effects during assessment including dry skin, stinging upon application, and staining of the skin.
Conclusion: There were minimal side effects in both groups suggesting that Peaceful Mountain Eczederm Rescue is as safe as a placebo gel.
Background:
Eczema is a general term for a variety of chronic inflammatory conditions of the skin. Eczematous skin often presents as a localized rash of itchy, red, dry, and scaly areas. Though poorly understood, the cause of eczema seems to be closely linked to heredity, and sensitization to one or many allergens. The mechanism behind the skin inflammation is an immune reaction that causes an increase in inflammatory cytokines. The condition is most often contracted in childhood, and diagnoses of asthma and hay fever often follow later in life1. Though eczema is not traditionally thought of as a severe condition, the societal burden it creates is significant. Estimates show more than 15 million Americans are affected with eczema of one form or another, and payments from insurance companies to cover the costs of their patients with eczema amount to over 1 billion dollars per year2.
In the course of treatment, clinicians will often discuss allergen exposure, and how to rule out various external allergens that may be exacerbating the condition. Lotions and emollients help to keep the skin hydrated and free of xeroses and may reduce the need for corticosteroids, but once an outbreak has begun, these topicals are often of little use. The medical standard of care most often recommended for eczema consists of topical corticosteroids used in short bursts to suppress symptoms while avoiding long-term use. This is due to the fact that long-term use of topical corticosteroids has been associated with skin atrophy, striae, and development of tolerance1. Two new treatments, topical tacrolimus and picrolimus, have recently been approved for use on eczema, but the long-term effects of its use are unclear. Several studies have discovered an increased prevalence of skin cancer in animals treated with the compounds3. Presently, no treatment for eczema that has been deemed efficacious at suppressing outbreaks has been approved for long-term use without the possibility of side effects1.
The present study was undertaken to determine the safety of Peaceful Mountain Eczederm Rescue a topically applied herbal cream. The cream contains herbs with anti-inflammatory, antiviral, anti-fungal, analgesic, and tissue-regenerating properties4.
Methods:
After giving written consent, twenty-two subjects were enrolled in this double-blind, placebo controlled trial, and randomized to receive either the IP or a placebo cream. Subjects were seen once a week for four weeks (total of 5 visits). Each weekly visit consisted of a verbal interview, a side effects survey filled out in the presence of the clinician, and a photograph of the treatment area.
Subjects were instructed to refrain from the use of any oral antihistamines, or corticosteroids. Though topical corticosteroid and emollient use was prohibited in the affected area, the use of an un-medicated moisturizing lotion (Cetaphil and Eucerin) was allowed. The first week was designated as a baseline week to assess each subject’s symptoms when free of treatment. The second and third week were designated as assessment weeks, during which the subjects were instructed to apply the assigned cream three times a day while continuing to fill out their side effect surveys. Subjects were given tubs of cream labeled only with their number. Subjects were instructed to saturate the affected area with the cream at each application. The last week was designated as a return to baseline week as a means of determining any lasting side effects of the IP.
Baseline characteristics were calculated, and are comparable for the test and placebo group (Table 1).
Variable
Test (n=20)
Placebo (n=19)
Age in years
47 (±18)
39 <±16)
Period of symptoms in years
5 (±17)
12 (±12)
No. of women (%)
13 (65)
13 (68)
Table 1 Baseline characteristics of participants. Values are averages (±standard deviation) unless otherwise stated.
Results:
Outcome
A total of 9 test subjects and 5 placebo subjects reported side effects during the trial. Three test subjects and 1 placebo subject reported side effects that only lasted during the first week of assessment (Fig 1). During the second week of assessment 5 test subjects and 3 placebo subjects reported side effects during that week of assessment. There were 5 test subjects and 1 placebo subject that reported side effects that continued through both weeks of assessment.
Fig 1 The number of side effects reported each week of assessment in both the test and placebo group.
Fig 2 The percent of test and placebo subjects that experienced dry skin, stinging upon application, and staining of skin during the assessment weeks of the study.
Discussion:
Both groups experienced stinging upon application and staining of the skin and the test group reported dry skin. This suggests that the test and placebo gels were similar in the type of side effects they caused. It was not reported if the subjects that experienced stinging upon application had open sores during the assessment weeks causing an increase in sensitivity or if the stinging would diminish over time. None of these side effects were viewed as dangerous and all side effects ceased when application was discontinued. These results suggest that the Peaceful Mountain Eczederm Rescue is a safe topical therapy.
Three side effects were reported in both groups including dry skin, stinging upon application, and staining of the skin. Of the test subject reporting side effects, 16% experienced dry skin, 37% reported stinging when the gel was applied, and 16% reported a temporary staining of the skin (Fig 2). The placebo group had 5% report stinging when the gel was applied, and 20% report staining of the skin.
References:
- Williams H C. Atopic dermatitis. N Engl J Med 2005; 352: 2314-24
- “Handout on Health: Atopic Dermatitis (A type of eczema).” National Institute of Arthritis and Musculoskeletal and Skin Diseases. April 2003. National Institutes of Health Department of Health and Human Services. 29 June 2005. http://www.niams.nih.gov/hi/topics/dermatitis/AtopicDerm.pdf
- “Alert for Healthcare Professionals: Pimecrolimus (marketed as Elidel).” U.S. Food and Drug Administration: Center for Drug Evaluation and Research. March 2005. U.S. Food and Drug Administration. 29 Jul. 2005. http://www.fda.gov/cder/drug/InfoSheets/HCP/elidelHCP.html
- Fleming T Ed. PDR for Herbal Medicines. 2nd ed. Medical Economics Company, Montvale, 2000
- Ruzicka, T. Atopic eczema between rationality and irrationality. Arch Dermatol 1998; 134: 1462-9
- Behrendt H, Ring J. Histamine, antihistamines and atopic eczema. Clin Exp Allergy 1990; 20(supp 4): 25-30
- Strange P, Skov L, Lisby S, Nielsen L P, Baadsgaard O. Staphylococcal enterotoxins B applied on intact normal and intact atopic skin induces dermatitis. Arch Dermatol 1996; 132: 27-33
- Wehner J, Neuber K. Staphylococcus aureus enterotoxins induce histamine and leukotriene release in patients with atopic eczema. Brit J Dermatol 2001; 145: 302-5
- Brown S, Reynolds N. Atopic and non-atopic eczema. Brit J Med 2006; 332: 584-588.