INTRODUCTION

We conducted a small double-blinded placebo-driven study on a select group of patients with the diagnoses of Rosacea, Photodamage/ Actinic Dermatitis, Acne, Seborrheic Dermatitis, and Perioral Dermatitis. Considering the pathology and etiology of these conditions, including the potential role of Demodex in the stimulation of erythema and inflammation patterns, we elected to proceed with administration of either the FaceDoctorx Soap or the placebo on a randomized basis. The patients selected were either started de novo, or more commonly, given the soap as a replacement for other allopathic topical and sometimes systemic treatments.

BRIEF OVERVIEW: “THE RED FACE”

The perception f redness of the face, or erythema, is a consequence most often of either a vascular or inflammatory component. Erythema can be an acute observation of the disease, and drug reactions; or long-term sequelae of many triggers, the most common of which are sun exposure, alcohol, and estrogens. When patients come to the dermatologist complaining of a red face, their immediate perception is they have a disease and they need a cure, without considering that their may be many other structural and physiological factors and variables that are not necessary disease states. In other words, some people are simply just redder than others.

Rosacea is one of the more common syndromes seen by physicians, especially dermatologists. It is an acne-like eruption affection mainly adults that can appear on the cheeks, nose, and forehead. The triggers can be classified as anything stimulatory or that can vasodilate, such as stress, sunshine, spicy foods, and caffeine, but the historical trigger has always been alcohol, remembered anywhere from the red face from a glass of wine to the WC Fields nose. Over 50% of all patients with Rosacea label these as one of their triggers. An important subset of this is Perioral Dermatitis, which has similar histological features but is usually more inflammatory, involves the creases of the face such as the lip and chin angles, and can be more closely linked to menses or estrogen supplements. Although these patients have more intense inflammation patterns, they are often approached in the same fashion as patients with Rosacea. Therefore, for the purpose of this study, they will be considered as one entity.

Much of the pathophysiology of Rosacea has been linked to hyperirritability, sebaceous gland hyperplasis, and plethora of new attention as a component. Prescription antibiotic creams, cleansers, and gels which have conventionally been used as anti-inflammatory and anti-microbial agents, have found new allies in sodium sulfacetamide and precipitated sulfur, as well as anti-parasitic therapies such as permethrin directed against the Demodex mite. It is this rationale that we have decided to examine this approach for treating Rosacea.

As mentioned, many patients with chronic Photodamage, also known as Chronic Actinic Dermatitis, Solar Elastosis, and Dermathoheliosis, experience facial Erythema as a long-term consequence of their days in the sun, not having the benefits of sunscreen as we do today. As a result, those patients are complaining of a ruddy, dry and irritated complexion filled with Telangiectasia (blood vessel streaks) and the look of a sailor or farmer, which is not appealing to many. Currently, there is no clear trigger for the histological changes although many have supported the notion that the atrophic changes in the superficial layers of the epidermis from long-standing sun exposure may allow the Demodex mite to increase in numbers as well as stimulate more aggressive inflammatory responses resulting in some of the coetaneous features.

Seborrheic Dermatitis is considered to be an inflammatory version of Dandruff with fine scales, Erythema, and a greasy appearance. It often affects the scalp and mid-face of patients of any age, including the cradle cap of infants. The exact mechanisms are not clear, but a strong relationship between Pitryosporum Ovale and the severity of flares has been demonstrated. In addition, the increased incidence in patients with neurological diseases such as Parkinson’s disease, in patients with AIDS, and in stroke patients, suggests that the immune systems compromise that these patients experience may allow the Pitryosporum Ovale and other micro-organisms, such as Demodex, a chance to grow without control and create increased inflammation patterns.


STUDY DESIGN

After patient selection based on the diagnosis and treatment failures, a “before soap” photograph was taken followed by a baseline assessment of the following symptoms and signs as well as on outline of the medications failed and potential triggers:

TABLE 1: STUDY PARAMETERS

Symptoms: Flushing, burning, perception of redness, itching, bumpiness
Signs: Erythema, Scales, Telangiectasia, Papulation, Dermatoheliosis

Usual medications failed:
Topical: Metronidazole, Sulfacetamide, Steroids, Sunscreens, Benzoyl Peroxide, Clindamycin, Anti-pruritic lotions
Systematic: Tetracycline, Minocycline

Potential Triggers: Solar exposure, cosmetics, stress, alcohol, foods, etc.

Soaps were numbered from 100-150 and randomly given to the patients in no particular order or sequence. The patients were instructed to apply the soap for 3-5 minutes twice a day and rinse off before application of any other medications or topical agents. They were to use the soap alone or as an adjunct to any other medications for a total of one month and then return for follow-up assessment. They were to note and record any adverse events and discontinue the soap immediately as well as discontinued used if they feel there were no results.

At the follow-up visit, an “after photo” was taken to compare the results of one months’ use of the soap. They were then offered to continue the soap at their own expense or discontinue it in favor of conventional allopathic treatments. An assessment of their improvement percentage, experiences, adverse effects, and benefits to their specific Dermatoses was also documented.

Some of the more common facial Dermatoses encountered in a dermatolosy practice include Rosacea, Acne, Seborrheic Dermatis, and the consequences of Photodamage, or “Dermatoheliosis.” There are many potential triggers of these conditions such as sunlight, stress, foods, and medications. There are also parasites and other organisms on the face that can work from within the ski to stimulate a flare of these disorders. The most common of these is the Demodex Folliculorum, which is a mite that lives in the hair follicle units on the face.

We attempt to approach the concept of reducing the activity of the Demodex mite as well as other triggers by more conventional prescription methods but often find frustration, non-compliance, or inconsistent responses. These patients are often frustrated, desperate, and willing to try new approaches as “they have tried everything.” Using the mechanisms of action of the faceDoctorx Soap in the application against these skin disorders, we are taking a medicated product that is simpler to use and directed a potential source of inflammation. Our efforts with this project were to create a double-blind placebo controlled study of a randomized population of these patients and assess their potential responses to the soap and determine its efficacy in control. Eventually, we hope to visualize the soap playing a role in the control of these conditions, either alone or in combination with other prescription or non-prescription medications.

As a result of the study, we found the FaceDoctorx Soap to help reduce many of the signs and symptoms of the conditions studied, especially in terms of reducing facial redness and some of the ruddy complexion changes from extensive Photodamage. In our opinion, the FaceDoctorx Soap will be very useful either as mono-therapy in more mild cases or as a very aggressive adjunctive treatment option in some of the more moderate cases given its ease of use, tolerability, and mechanism of action. It did not seem to interfere with sunscreen or other moisturizers, which is essential in the treatment of these patients. We hope to incorporate the soap in regular yes in the clinic.

RESULTS:

A total of 42 patients were selected for the study and follow-up. Four patients were either lost to follow-up or discontinued the soap before the completion of one month. In addition, it should be noted that of the placebo group, two patients purchased the soap and finished 2 more months of treatment with FaceDoctorx, which led to improvement. These patients were subsequently added to the FaceDoctorx group of patients counted.

A review of the overall data revealed a strong correlation of improvement in most patients who received the FaceDoctorx Soap compared to the placebo group. These were subdivided by diagnosis and distribution by the following groups:


TABLE 2: STUDY DEMOGRAPHICS 

                              Rosacea/P.Derm/Acne      Photodamage     Seb Derm

FaceDoctorx                        16                                   4                         1
Placebo                                18                                   2                         1

For simplicity, the Rosacea and Perioral Dermatitis groups were combined, but this in no way should minimize the importance of recognizing these conditions as its own disease state. However, for our purposes, the Pathophysiology and Histological findings are similar for all cases and can allow for a combination of these patients. In addition, any patients with symptoms suggestive of Rosacea were classified in that group, regardless of any other concomitant condition. Finally, the two patients labeled above with Seborrheic Dermatitis that entered the study also demonstrated some degree of Photodamage but were separately classified.

Improvement was based on a zero to ten scales where zero represented discontinuation or lost to follow-up, one was on improvements and ten was the maximum improvement. This was interrupted considering the soap as an adjunctive vs. Replacement therapy as well as the potential need for a longer duration of therapy than one month. Finally, it was taken into consideration whether or not the patient was given placebo or FaceDoctorz only after the experiment was completed and the code was given for review.

The following represents the average patient improvement obtained y each group. This statistic is taken into account by the average number of the scale based ion the individual response, eliminating the zero scores, which did not contribute to any statistical significance:

TABLE 3: AVERAGE IMPROVEMENT SCORES

                               Rosacea/P.Derm/Acne      Photodamage     Seb Derm

FaceDoctorx                        6.2                                3                        5
Placebo                                4.3                                6.5                     5

Many of the comments in the study were recorded and discussed with the patients although they were unaware of the soap they were given. These included the following:

“A lot cleaner” “Less red” “Less bumpy” “Less scaly”
“Made my face clear” “How do I get more” “Really enjoyed it”
“Fantastic, my face is clear” “it looks a lot better”

Evaluation of the data reveals a stronger correlation of positive comments to the FaceDoctorx group than the placebo group. In addition, there was a stronger correlation to the Perioral Dermatitis group of positive results than any other group. It should be made clear that the majority of patients with overlap conditions, which usually involved a Rosacea subset with any of the other, had a much better comment profile than the other groups combined.

THE ROLE OF PLACEBO AND VEHICLE

Unlike the placebo “sugar pill” that are used in studies of oral medications, the role of the vehicle in dermatology agents is very significant, as it is basically the delivery service for the medicine. But what are often overlooked are the properties of the vehicle itself. These can be moisturizing, soothing, and easy to the skin’s texture, which are beneficial to the patient, although at worst it can be irritating and drying and therefore prohibit the use of his medicines. The vehicle in this study, the bar of soap, had not only its own contribution to alleviating many of the patients’ symptoms but in some cases actually proved to be beneficial in and of themselves. It should there fore not be discounted in favor of the FaceDoctorx Soap that the unique base itself could be a contributing factor to the improvement of many patients. As an aside, the novelty and ease of use of a soap in patients who would also be prescribed a cream or facial cleanser would be very beneficial traits to an adjunctive therapy often necessary for the patient who feels that they have “tried everything.”