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Treatment of herpetic cold sores with an extract of Sarracenia Purpurea

Mark V Dah

Aubio Life Sciences, LLC, 215 Northeast 1st Avenue, Delray Beach, Florida 33444, USA

E-mail : aa

Amy L Beckstead

Aubio Life Sciences, LLC, 215 Northeast 1st Avenue, Delray Beach, Florida 33444, USA

Lawrence A Rheins

Aubio Life Sciences, LLC, 215 Northeast 1st Avenue, Delray Beach, Florida 33444, USA

DOI: 10.15761/GOD.1000204

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Abstract

Cold sores result from skin infections with the herpes simplex. There is a need for an effective way to treat herpes cold sores with a safe, topically-applied botanical extract. Aqueous extracts of leaves from the pitcher plant Sarracenia purpurea prevent normal replication of herpes simplex virus in human cells in vitro. This single-center, double blind, placebo-controlled, randomized, proof of concept, pilot clinical trial compared treatments of recurrent herpes simplex labialis. A gel containing an extract of S. purpurea (SP-gel) was compared to its vehicle gel base. The study was designed to assess the ability of the preparations to mitigate cold sores, ameliorate sensorial symptoms and improve quality of life.

Use of SP-gel was associated with improvement in mean global assessment scores throughout the study period with significant improvement from baseline by day 4. Mean global assessments at day 1 were highest (worst) of all study visits and decreased rapidly, consistent with initiation of treatment and rapid improvement and rapid relief of symptoms by both gels after the first visit. Analysis of the change from baseline (day 1) for clinical grading scores between the test materials indicated a statistically significant difference for status of lesions at day 2, in favor of SP-gel over vehicle control. The clinical status of lesions at day 2 was judged significantly better after one day of treatment with SP-gel compared to vehicle control. The study contained too few subjects to prove that many other observed trends for superiority of SP-gel were statistically significant. However, results were encouraging. Applications of SP-gel safely improved appearance, symptoms, and various quality of life measures.

Key words

 herpes simplex, cold sore, sarracenia, botanical

Abbreviations

SP-gel: aqueous extract of Sarracenia purpurea in gel base, VG: Vehicle gel control, HSV: herpes simplex virus

Introduction

Cold sores result from recurrent skin infections caused by herpes simplex virus (HSV). The virus hides in a dormant (latent) state in nerves until activated, often by a cold, fever, trauma, sunburn, or hormonal change [1-3].

One or more small blisters appear atop a tender, swollen red base [3,4]. The blisters rupture to leave a “sore”—a small ulcer often covered with a yellow or black crust. The occurrence of the lesions is accompanied by symptoms of pain, tingling, or local tenderness. In most cases, the cold sores heal within two weeks, even without treatment [4]. There is need for a safe and effective natural botanical treatment to alleviate symptoms and support the healing process [5]. Recently plant extracts have been incorporated into a lip balm for daily use and into a gel for application to cold sores after they develop. One of the botanical extracts in these formulations is derived from Sarracenia purpurea, the water pitcher plant. Extracts of this plant were used in the past for treatment of smallpox. Aqueous extracts of S. purpura prevent normal replication of herpes simplex viruses in human cells in vitro (unpublished data). We found that applications of a gel containing several plant extracts including S. purpurea to HSV cold sores was associated with prompt healing, decreased symptoms, and improved quality of life.

Methods

This single-center, double blind, placebo-controlled, randomized, proof of concept, pilot clinical trial compared treatment of recurrent herpes simplex labialis with a gel containing an extract of S. purpurea (SP-gel) to its vehicle gel base (VG). The study was designed to assess the ability of the preparations to mitigate the signs of cold sores and to assess the ability of SP-gel to ameliorate sensorial symptoms and improve quality of life. The study design was approved by an institutional review board (IRB) and all subjects gave oral and written informed consent.

To be included in the study the subject must have had at least five episodes of herpes simplex labialis in the past year. Prospective subjects were screened for qualification, which occurred on the same day or up to 7.2 months prior to visit 2 (day 1). Day 1 procedures occurred within 24 hours after onset of prodromal symptoms or after appearance of an actual cold sore. Qualified subjects entered the study if they were experiencing prodromal symptoms at the day 1 visit or had an emerging cold sore lesion that developed within 12 prior to the day 1 visit.

Subjects were assigned to a treatment or vehicle control group using generated random numbers in groups of ten subjects. Some subjects received SP-gel, which was a gel formulation containing an aqueous extract of leaves of S. purpurea, leaf juice from Aloe barbarensis, and extracts of other plants. The other subjects received the nearly identical vehicle gel (VG) that contained aloe leaf juice and the other ingredients but did not contain extracts of sarracenia sp.

Subjects initiated treatment during the prodrome or at the first sign of skin lesion. Subjects were instructed to apply their assigned gel once every hour for the first four hours and then once every four hours if awake until the lesions healed. Clinical evaluations were conducted daily over the course of 7 consecutive days (days 1-7). Neither the subject nor the investigator knew the composition of the study material consistent with the double blind nature of the study. At each visit, subjects were clinically graded by the investigator for global severity of HSV labialis lesions, lesion counts on or around the lips and chin (papules, pustules, vesicles, and crusting ulcer), appearance of the target lesion (erythema, elevation/height, diameter, lesion discomfort/pain to touch), and clinical status (Table 1). Center view digital images of each subject were taken using a VISIA CR photo-station (Canfield Imaging Systems, Fairfield, New Jersey) with a Canon Mark II 5D digital SLR camera (Canon Incorporated, Tokyo, Japan) under standard lighting 1 and 2, cross-polarized, and parallel polarized lighting conditions. The images were analyzed for lesion area by computer.

Table 1. Clinical grading scales

Global Assessment

0

Clear

Lesions are no longer present. Residual erythema may be present on the affect area.

1

Almost Clear

For example, lesion(s) are relatively flat in appearance with or without spotty residual crust.

2

Mild

For example, small size lesion(s) that are mildly red and elevated with or without crusting. Bleeding may be evident.

3

Moderate

For example, moderate size lesions that are moderately red and elevated without blistering.

4

Severe

For example, two or more large lesions intensely red and elevated with or without blistering and bleeding. Adjacent lesions may be coalescing.

Lesion Counts

  • Papules
  • Pustules
  • Vesicles
  • Ulcer crusting

Appearance

        Erythema

       

0 = None

1 = Slight

2 = Mild

3 = Moderate

4 = Severe

        Elevation/Height

0 = Completely flat

1 =  Slightly raised,

2 =  Mildly raised

3 =  Moderately raised

4 =  Severely raised

        Diameter by Measurement

       

0 =  No lesion visible

1 =  Slightly visible lesion diameter, ≤ 1.0 mm

2 =  Small lesion diameter, ≤ 2.0 mm

3 =  Medium lesion diameter, < 5.0 mm

4 =  Large lesion diameter, ≥ 5.0 mm

        Discomfort of Lesion

1 =  Slight

2 =  Mild

3 =  Moderate

4 =  Severe

        Status of lesion

       

0 =  Clear

1 =  Resolving

2 =  Static

3 = Spreading

       

Table 2. Subject disposition

All Subjects

Cell 1

Cell 2

n

n

n

Enrolled Subjects

23

13

10

Completed Subjects (PP Population)

21

11

10

Discontinued Subjects

2

2

0

Reason for Discontinuation

 

 

 

Investigator Decision

1

1

0

Lost to follow-up

1

1

0

 

Table 3. Summary of demographic information

All Subjects

SR Gel

Vehicle Gel

N

21

11

10

Age (Years)

 

 

 

Mean

41.5

43.5

39.3

Standard Deviation

10.5

11.6

9.2

Minimum

26

26

29

Median

44.0

45.0

35.5

Maximum

60

60

54

n

(%)

n

(%)

n

(%)

Sex

 

 

 

 

 

 

Male

4

(19.0)

2

(18.2)

2

(20.0)

Female

17

(81.0)

9

(81.8)

8

(80.0)

Ethnicity/Race

 

 

 

 

 

 

Asian

1

(4.8)

0

(0.0)

1

(10.0)

Black or African American

5

(23.8)

2

(18.2)

3

(30.0)

Hispanic or Latino

4

(19.0)

2

(18.2)

2

(20.0)

White

10

(47.6)

6

(54.5)

4

(40.0)

Multi-Racial

1

(4.8)

1

(9.1)

0

(0.0)

Subjects assessed their level of discomfort of the treatment area for tingling, itching, burning, pain, and stinging sensations utilizing a 10 cm Visual Analog Scale. At day 7, subjects completed an exit questionnaire regarding feelings/quality of life while having the cold sore, progression and responses to treatment of the cold sore, and other test material attributes.

Statistics

Changes from baseline for grades and measures were statistically evaluated by the Wilcoxon signed-rank test. Testing hypothesis was that the mean change from baseline (day 1) was equal to zero. Image analysis data were calculated from the paired t-test. Testing hypothesis was that the mean change from baseline (day 1) was equal to zero. Treatments were compared using a two-sample t-test. Testing hypothesis was that the mean change from baseline (day 1) was equal between the 2 treatments. Questionnaire data were analyzed by the two-sample t-test. Testing hypothesis was that the mean score was equal between the 2 treatments. Significance was assigned for a difference of p ≤ 0.05.

Results

A total of 21 subjects participated in the study. Of these, 11 received SP-gel and 10 received VG. There was no “no treatment” control. Demographical information is provided in s 2 and 3. Clinical global assessments at day 1 visit were similar for each group. Use of SP-gel was associated with improvement in mean global assessment scores throughout the study period with significant improvement from baseline by day 4 (p=0.004). Improvement from baseline was maintained at days 5 (p=0.007), 6 (p=0.006), and 7 (p=0.007). Mean global assessments at day 1 were highest (worst) of all study visits and decreased rapidly, associated with rapid improvement and rapid symptom relief by both gels after the first visit, consistent with healing.

Analysis of the change from baseline (day 1) for clinical grading scores between the test materials indicated a statistically significant difference for status of lesions at day 2, in favor of SR-gel over VG (p=0.004). Changes of lesion size from baseline were generally favorable for both SP-gel and for VG. Mean scores decreased over the study period. Computer image analysis of cold sores treated with SP-gel showed statistically significant decreases in size from baseline as early as day 4 (p=0.045), and this continued to be significant compared to baseline throughout the rest of the study at days 5 (p=0.036), 6 (p=0.021), and 7 (p=003). In contrast, healing with VG did not reach significant mean size reduction from baseline until day 7 (p=0.012). Mean lesion diameter clinically decreased more with SP-gel than with VG to an almost significant difference (p=0.074 at day 6) and to significance at day 7 (p=0.035) compared to baseline.

Papule size decreased more with SP-gel than with VG, to a nearly significant difference (p=0.063 at days 6 and 7) compared to baseline, and with trend compared to treatment with VG (day 6 p=0.294 and day 7 p=0.232). Mean erythema scores decreased more with SP-gel than with VG, to an almost significant difference (p=0.055 at days 4 and 5) compared to baseline, and with trend compared to VG (p=0.262 and 0.380). The mean difference of papule severity was significantly improved from day 1 to day 7 (p=0.031). Mean elevation decreased rapidly with SP-gel treatments. Mean elevation compared to baseline decreased significantly by day 4 (p=0.016) and mean difference from baseline remained statistically significant through day 7 (p<0.005).

  1. mage analysis showed an increase in size from day 1 to day 2 for both SP-gel (mean increase 548 units) and VG (mean increase 3,355 units). In other words, the lesions treated with SP-gel did not enlarge as much over the first day compared to the enlargement of lesions treated with VG. This did not reach statistical significance (p=0.265). Image analysis of the lesion size also showed statistically significant improvements for SP-gel starting at day 4 until day 7. Comparisons of lesion size by image analysis showed greater mean decrease in size from mean baseline size at all visits after day 2 compared to VG.

Subjective symptoms were assessed at each visit using a VAS whereby the subject denoted the severity of a symptom on a non-numerical unmarked line to show symptom intensity from “no symptom” to “worst possible symptom.” General level of discomfort mean scores fell rapidly in subjects treated with SP-gel. Mean scores for SP-gel during the first 5 days was 3.85, 2.82, 1.47, 1.51, and 1.50 compared to VG of 3.42, 2.73, 2.42, 2.50, and 2.04.

Mean discomfort/pain to touch decreased more rapidly for SP-gel than for VG between days 1 and 2. Mean decrease in VAS scores from baseline were 28% lower for SP-gel compared to 8% lower for VG, and with trend comparing favorably for SP-gel compared to VG (p=0.359). The decrease in mean discomfort/pain scores compared to baseline reached significance at day 3 (p<0.05) and continued, while none of the mean discomfort scores for VG reached significance through day 7. A breakdown of symptoms allowed comparison of different types of symptoms between the two test substances during clinic visits on sequential days (days 2-7). Differences in mean symptom scores generally favored SP-gel. Specifically, more subjects using SP-gel reported less severe symptoms at each evaluation day (tingling=6/0 i.e. all six subjects favored SP-gel over VG in relief of tingling on each of the six days, itching = 3/3; burning = 6/0; pain = 4/2; stinging = 5/1; total 24 out of 30 scores favored SP-gel). Head-to-head comparison between treatments showed no statistically significant advantages.

For each symptom, there were also 6 daily evaluations by each subject recorded by the subject in his/her diary. Subjects evaluated treatments by VAS at home immediately after applications and recorded both time of day and score. These data show SP-gel rapidly reduced mean discomfort symptoms. All symptoms (tingling, itching, burning, pain, stinging and tingling) mean scores generally decreased during the study. Not all patients had all symptoms. Mean pain scores were less for SP-gel than VG except at day 7. Of subjective symptoms evaluated by VAS, the intensity of itching was greatly reduced by SP-gel. Full 81% of subjects improved by day 2. Mean discomfort scores after applications at home generally favored SP-gel, but never achieved significant difference. For each subject, there were 25 diary assessments of discomfort after day 1 (5 on each day). Relief from discomfort was better for Aubio in 20 and better with VG in only 5.

There were no severe adverse effects. SP-gel was well tolerated by the subjects, with no statistically significant increases in scores for subject assessment of irritation at any study time point when compared with baseline (day 1) scores. In fact, after using SP-gel, statistically significant improvements were observed for tingling, itching, burning, pain, and stinging after 7 days of use.

Quality of life was assessed by exit questionnaire to learn how much the episode had affected activities of daily living. In this analysis, a low score is favorable to a high score. Comparison analysis of mean quality of life parameters showed subjects using SP-gel tended to have less interference with quality of life parameters than those using VG. Mean differences favored SP-gel with subjects using the gel reporting less interference of quality of life regarding humiliation, worries about scarring, anger, embarrassment, worries about worsening, interference with sex life, interfering with relationships, causing problems for a loved one, and difficulty displaying affection (total of 9 attributes). Those attributes seeming better after treatment with VG were depression, frustration, shame, tendency to stay at home, tendency to do things alone, effects on work or activities, and social life impact (total 7 attributes). Daily mean scores for enjoyment of daily activities (a quality of life parameter) after day 1 favored SP-gel at 24 evaluation points and VG at only 1.

Subjects often had used one or more remedies in the past. All 11 subjects using SP-gel thought that it worked better than these other treatments. VG worked better than previous treatments in 6 of 9 subjects. Of 21 subjects, 19 said they would use this product again if they had a cold sore (SP-gel 10, VG 9).

Discussion

Outbreaks of cold sores caused by the HSV are common. Infections of skin lead to infections in neurons. Once inside neurons, HSV enters a latent phase where epigenetic actions of the host silence genes of the virus preventing replication and destruction by immune reactions. Reactivation is associated with prodromal symptoms such as itch, pain, or tingling. Soon thereafter, telltale grouped, tense vesicles appear on the skin. Most people want the cold sore and its symptoms to disappear quickly. There is need for a botanically-based cold sore remedy that quickly and safely relieves symptoms and signs of the infection and that fosters healing of the cold sore itself.

Sarracenia purpurea (SP) is commonly known as the northern pitcher plant, since it looks rather like a pitcher and holds water like a pitcher (Figure 1). The plant likes to grow in murky swamps and bogs. Here the plant collects dew and rainwater to fill its pitcher. Insects are attracted to the top of the plant by the plant’s bright colors and sweet nectar. The rim at the top of the pitcher edge is slippery, and insects often fall into the water and drown. The plant secretes proteases and phosphatases into the pitcher. These digest the prey. Digestion also results from the actions of bacteria that inhabit the stagnant water inside the pitcher. The proteins and organic nutrients derived from degraded insects provide vital nutrients for the plant.

Figure 1.  Sarracenia purpurea, the pitcher plant.  The flower holds water like a pitcher. Insects and other organisms fall into the water and drown.  The plant has developed antimicrobial defenses and therefore is not injured by the putifying bacteria, fungi, and viruses that colonize the water and dead prey.

Plants, like human beings, become infected by viruses, bacteria and fungi [6]. The water in the serracenia sp. plant teems not only with dissolving insects but also with putrefying bacteria, fungi and viruses [7-9]. Over generations, the pitcher plants have developed natural defense systems to protect themselves from injury and infection.

The antiviral qualities of parts from the pitcher plant have been known for at least a century and, indeed, references to its use in treating smallpox were published in 1862 [10]. Smallpox was an often-fatal diseased cause by infection of human beings by the pox virus variola. At the time, the epidemics of smallpox were killing and maiming large percentages of people around the world. Native Americans, among others, discovered the healing properties of the pitcher plant and ingested and applied extracts and plant parts to promote healing and to minimize scarring. Modern science has shown that extracts of SP do stop replication of both the smallpox virus (variola) and the smallpox-related vaccinia virus [11].

Extracts of SP also inhibit HSV (unpublished data). These extracts have been incorporated into a gel for application to skin to help people affected by herpetic cold sores. SP-gel, commercially available as Aubio™ Cold Sore Treatment Gel, was tested here. We conducted a small pilot study designed to learn how well an extract of SP could help cold sore sufferers. As shown by this study, application of an aqueous extract of SP in gel base alleviates symptoms, supports healing, and improves the appearance of cold sores caused by HSV.

Analysis of the change from baseline (day 1) for clinical grading scores between the test materials indicated a statistically significant difference for status of lesions at day 2, in favor of SP-gel over vehicle control (p=0.004). showed an increase in size of sores from day 1 to day 2 for both SP-gel (mean increase 548 units) and VG (mean increase 3,355 units), but the sores treated with SP-gel did not enlarge as much over the first day compared to enlargement of cold sores treated with VG. This effect did not obtain statistical significance (p=0.265) in this small study, but results suggest that early applications of SP-gel may limit size. Comparisons of lesion diameter by image analysis showed greater mean decrease in size from mean baseline size at all visits after day 2 for SP-gel compared to VG

Gowey also conducted a double-blind study on 33 subjects with HSV infections comparing an extract of SP in a different gel with a placebo gel base [12]. Applications of the formulations were repeated every 3-4 hours and often gave subjects “immediate relief” from pain and fostered healing, which shortened the course of the infection. Gowey found statistical superiority (p<0.05) for the SP mixture versus placebo gel for assessments of lesion diameter and pain. The study is not directly comparable with our study because methods, endpoints, measurements, and statistical analysis are different. Some of Gowey subjects had HSV type II infections.

We used the SP vehicle as our placebo. This set a high bar for detection of differences. Likely the vehicle itself also had some role in relieving symptoms and fostering healing, since it contained an extract of Aloe barbarensis leaf juice, which is well known to sooth injured skin and foster healing, too [13]. Both SP-gel and VG generally shortened healing times, reduced symptoms, and improved quality of life. All 11 subjects treated with SP-gel thought that it worked better than other treatments they had used previously. VG worked better than previous treatments in 6 of 9 subjects. Of 21 subjects, overall, 19 said they would use this product again if they had a cold sore (SP-gel 10, VG 9).

The study was a small one comprised of only 21 subjects. It was designed to establish the validity of the methods and measurements. A much larger study might well have uncovered more statistically significant differences between SP-gel and the comparable vehicle gel. Other much larger studies of subjects with recurrent HSV cold sores have often struggled to show superiority of topical applications of active agents when compared to placebos or other active agents [14-17]. This may be because viral replication is maximal during the earliest phases of recurrence. Treatments must be initiated early to abort viral replication at a lesion’s early age [5].

The study confirmed safety found in preclinical studies. No subject developed allergy or irritation from treatments. No severe adverse effects were reported or observed.

In summary, this single-center, double-blind, placebo-controlled, randomized, small, proof of concept, pilot clinical trial compared treatment of cold sores with a gel containing an extract of S. purpurea (SP-gel) to treatment with the vehicle gel base (VG). The study contained too few subjects to prove that many observed trends for superiority of SP-gel were statistically significant. However, results were encouraging. Cold sores were safely treated with a botanical gel that contains an extract of the pitcher plant SP. Applications improved appearance, symptoms, and various quality of life measures. In addition, applications worked rapidly, bringing cold sore sufferers fast relief.

Acknowledgement

This study was conducted at the Texas Research Center with Thomas J Stephens & Associates, Inc, Richardson, Texas 75081

Funding support

This study was sponsored by Aubio Life Sciences, LLC, makers of Aubio™ Cold Sore Treatment Gel. Dr. Dahl is a consultant and director of clinical trials and Dr Rheins and Ms. Beckstead were employees.

References

  1. Fatahzadeh M, Schwartz RA (2007) Human herpes simplex labialis. Clin Exp Dermatol 32: 625-630. [Crossref]
  2. Pereina FA (1996) Herpes simplex: evolving concepts. J Am Acad Dermatol 35: 503-520. [Crossref]
  3. Whitley RJ, Roizman B (2001) Herpes simplex virus infections. Lancet (London, England) 357: 1513-1518. [Crossref]
  4. Spruance SL (1992) The natural history of recurrent oral-facial herpes simplex virus infection. Semin Dermatol 11: 200-206. [Crossref]
  5. Cunningham A, Griffiths P, Leone P, et al. (2012) Current management and recommendations for access to antiviral therapy of herpes labialis. J Clin Virol 53: 6-11. [Crossref]
  6. Armijo G, Schlechter R, Agurto M, Muñoz D, Nuñez C, et al. (2016) Grapevine Pathogenic Microorganisms: Understanding Infection Strategies and Host Response Scenarios. Front Plant Sci 7: 382. [Crossref]
  7. Buch F, Rott M, Rottloff S, et al. (2013) Secreted pitfall-trap fluid of carnivorous Nepenthes plants is unsuitable for microbial growth. Ann Bot 111: 375-383. [Crossref]
  8. Krieger JR, Kourtev PS (2012) Bacterial diversity in three distinct sub-habitats within the pitchers of the northern pitcher plant, Sarracenia purpurea. FEMS Microbiol Ecol 79: 555-567. [Crossref]
  9. Siragusa AJ, Swenson JE, Casamatta DA (2007) Culturable Bacteria Present in the Fluid of the Hooded-Pitcher Plant Sarracenia Minor Based on 16S rDNA Gene Sequence Data. Microb Ecol 54: 324-331. [Crossref]
  10. Miles HS (1862) On the employment of sarracenia purpurea, or indian pitcher plant, as a remedy for smallpox. The Lancet 80: 430-431.
  11. Arndt W, Mitnik C, Denzler KL, White S, Waters R, et al. (2012) In vitro characterization of a nineteenth-century therapy for smallpox. PLoS One 7: e32610. [Crossref]
  12. http://www.naturopathsinternational.org/uploads/2/7/0/1/27012251/hsv1-2.pdf
  13. Dat AD, Poon F, Pham KB, Doust J (2012) Aloe vera for treating acute and chronic wounds. Cochrane Database of Systematic Reviews CD008762[Crossref]
  14. Khemis A, Duteil L, Coudert AC, Tillet Y, Dereure O, et al. (2012) Evaluation of the efficacy and safety of a CS20® protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial. J Eur Acad Dermatol Venereol 26: 1240-1246. [Crossref]
  15. Harmenberg J, Öberg B, Spruance S (2010) Prevention of Ulcerative Lesions by Episodic Treatment of Recurrent Herpes Labialis: A Literature Review. Acta Derm Venereol 90: 122-130. [Crossref]
  16. Woo S-B, Challacombe SJ (2007) Management of recurrent oral herpes simplex infections. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 103: Suppl:S12. [Crossref]
  17.   Chi C-C, Wang S-H, Delamere FM, Wojnarowska F, Peters MC, (2015) Interventions for prevention of herpes simplex labialis (cold sores on the lips). Cochrane database Syst Rev 8: CD010095. [Crossref]

Editorial Information

Editor-in-Chief

Prof. Torello Lotti

Article Type

Research Article

Publication history

Received date: January 22, 2017
Accepted date: February 15, 2017
Published date: February 18, 2017

Copyright

©2017 Dahl MV. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Citation

Dahl MV, Beckstead AL, Rheins LA (2017) Treatment of herpetic cold sores with an extract of Sarracenia Purpurea. Glob Dermatol 4: doi: 10.15761/GOD.1000204

Corresponding author

Mark V Dahl, MD

Department of Dermatology, Mayo Clinic College of Medicine and Science, 13400 East Shea Boulevard, Scottsdale, Arizona 85259, USA Tel: 480-301-6172; 480-451-9801; Fax: 480-301-9196

Table 1. Clinical grading scales

Global Assessment

0

Clear

Lesions are no longer present. Residual erythema may be present on the affect area.

1

Almost Clear

For example, lesion(s) are relatively flat in appearance with or without spotty residual crust.

2

Mild

For example, small size lesion(s) that are mildly red and elevated with or without crusting. Bleeding may be evident.

3

Moderate

For example, moderate size lesions that are moderately red and elevated without blistering.

4

Severe

For example, two or more large lesions intensely red and elevated with or without blistering and bleeding. Adjacent lesions may be coalescing.

Lesion Counts

  • Papules
  • Pustules
  • Vesicles
  • Ulcer crusting

Appearance

        Erythema

       

0 = None

1 = Slight

2 = Mild

3 = Moderate

4 = Severe

        Elevation/Height

0 = Completely flat

1 =  Slightly raised,

2 =  Mildly raised

3 =  Moderately raised

4 =  Severely raised

        Diameter by Measurement

       

0 =  No lesion visible

1 =  Slightly visible lesion diameter, ≤ 1.0 mm

2 =  Small lesion diameter, ≤ 2.0 mm

3 =  Medium lesion diameter, < 5.0 mm

4 =  Large lesion diameter, ≥ 5.0 mm

        Discomfort of Lesion

1 =  Slight

2 =  Mild

3 =  Moderate

4 =  Severe

        Status of lesion

       

0 =  Clear

1 =  Resolving

2 =  Static

3 = Spreading

       

Table 2. Subject disposition

All Subjects

Cell 1

Cell 2

n

n

n

Enrolled Subjects

23

13

10

Completed Subjects (PP Population)

21

11

10

Discontinued Subjects

2

2

0

Reason for Discontinuation

 

 

 

Investigator Decision

1

1

0

Lost to follow-up

1

1

0

 

Table 3. Summary of demographic information

All Subjects

SR Gel

Vehicle Gel

N

21

11

10

Age (Years)

 

 

 

Mean

41.5

43.5

39.3

Standard Deviation

10.5

11.6

9.2

Minimum

26

26

29

Median

44.0

45.0

35.5

Maximum

60

60

54

n

(%)

n

(%)

n

(%)

Sex

 

 

 

 

 

 

Male

4

(19.0)

2

(18.2)

2

(20.0)

Female

17

(81.0)

9

(81.8)

8

(80.0)

Ethnicity/Race

 

 

 

 

 

 

Asian

1

(4.8)

0

(0.0)

1

(10.0)

Black or African American

5

(23.8)

2

(18.2)

3

(30.0)

Hispanic or Latino

4

(19.0)

2

(18.2)

2

(20.0)

White

10

(47.6)

6

(54.5)

4

(40.0)

Multi-Racial

1

(4.8)

1

(9.1)

0

(0.0)

Figure 1.  Sarracenia purpurea, the pitcher plant.  The flower holds water like a pitcher. Insects and other organisms fall into the water and drown.  The plant has developed antimicrobial defenses and therefore is not injured by the putifying bacteria, fungi, and viruses that colonize the water and dead prey.