Treatment of Chronic Paronychia: A Double Blind Comparative Clinical Trial Using Singly Vaseline, Nystatin and Fucidic Acid Ointment

doi:10.4236/jcdsa.2013.34038

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Journal of Cosmetics, Dermatological Sciences and Applications, 2013, 3, 250-255

Published Online December 2013 (http://www.scirp.org/journal/jcdsa)

http://dx.doi.org/10.4236/jcdsa.2013.34038

Open Access JCDSA

Treatment of Chronic Paronychia: A Double Blind

Comparative Clinical Trial Using Singly Vaseline,

Nystatin and Fucidic Acid Ointment*

Khalifa E. Sharquie1#, Adil A. Noaimi2, Sunbul A. Galib3

1Scientific Council of Dermatology & Venereology, Iraqi Board for Medical Specializations, Department of Dermatology &

Venereology, College of Medicine, University of Baghdad, Baghdad, Iraq; 2Department of Dermatology & Venereology, College of

Medicine, University of Baghdad, Baghdad, Iraq; 3Department of Dermatology & Venereology, Baghdad Teaching Hospital, Bagh-

dad, Iraq.

Email: #[email protected]

Received September 12th, 2013; revised October 10th, 2013; accepted October 18th, 2013

cense, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Background: Chronic paronychia is a chronic inflammatory reaction of the proximal and lateral nail folds of multifac-

torial in etiology like irritant, bacterial and monilial causes. But housewife work is a major cause of chronic paronychia.

Objective: To assess the efficacy and prophylactic effects of Vaseline by occlusion of nail folds in comparison with

nystatin ointment and fucidic acid in treatment of housewife chronic paronychia. Patients and Methods: This double,

blinded, comparative therapeutic, clinical trial is conducted at the Department of Dermatology-Baghdad Teaching Hos-

pital from May 2010 to May 2011. Eighty female housewife patients with chronic paronychia were included in this trial.

They were divided into three groups according to the following therapeutic model: Group A treated by Vaseline con-

sisted of 40 patients; Group B and Group C treated by nystatin ointment, fucidic acid ointment respectively and each

group consisted of 20 patients. All demographic points related to the disease were recorded from all patients. Invented

score system was applied to assess the severity of disease and the response to therapy. Patients had used therapy twice

daily on the proximal and lateral nail folds. Treatment duration was 12 weeks. Results: Group A (Vaseline): The re-

covery rate after 12 weeks of treatment was 26 (65%) patients, while there was no recovery in 14 (35%) patients. Group

B (Nystatin ointment): The recovery rate after 12 weeks was 13 (65%) cases and there was no recovery in 7 (35%)

patients. Group C (Fucidic acid ointment): The recovery rate 12 weeks of treatment was 12 (60%) patients and there

was no recovery in 8 (40%) patients. The earliest signs of recovery in all groups were decreased in nail fold tenderness,

redness, swelling followed by improvement in the nail shape, then decreased in the separation of proximal nail fold from

nail bed followed by re-growth of cuticle. There was significant difference in clinical response before and after therapy

in all groups (P ≤ 0.0001) while there was no statistical significant difference when the three groups were compared

with each other (P = 0.784). Conclusions: Vaseline occlusion therapy of the nail folds in patient with chronic par-

onychia was enough to induce recovery from the disease and there was no statistical significant difference when com-

pared with nystatin or fucidic acid treatment of chronic paronychia.

Keywords: Housewife; Paronychia; Vaseline; Occlusive Therapy

1. Introduction

Chronic paronychia is a major health problem of which

housewife paronychia is the main type seen in daily

clinical practice [1].

The etiopathogenesis is multifactorial, but the wet con-

dition during housewife work will cause loss of nail cuti-

cle followed by separation of proximal and lateral nail

folds and this will make a dead space thus allowing the

entrance of water, detergents, bacteria under the nail

folds followed by inflammation leading to the main fea-

tures of chronic paronychia mainly swelling of the nail

folds, nail dystrophy; this is so-called wet theory [2].

*Disclosure: This study is an independent study and not funded by any

drug company.

#Corresponding author. Accordingly, the presence of candida and bacteria like

Treatment of Chronic Paronychia: A Double Blind Comparative Clinical Trial

Using Singly Vaseline, Nystatin and Fucidic Acid Ointment

251

Staph aureus, alpha, beta and gamma-haemolytic Strep-

tococci, Klebsiella pneumonia, Bacteroides species and

Coliform, Pseudomnas aeruginosa, Proteus species and

other organisms as Diphtheroids, Streptococcus fecalis,

and Staphphylococcus albus are considered as secondary

invader in the pathogenesis of chronic paronchia [3].

Hence, the aim of therapy is to close the so-called dead

space and encourage the adhesion of nail cuticle and nail

folds thus preventing the entrance of water, detergents

and bacteria. Therefore, the management of chronic par-

onychia should start by prevention of wet conditions and

giving antimicrobial agents to stop the process of in-

flammation, but unfortunately, many practicing derma-

tologists give antifungal, antibacterial drugs for long time

aiming to enhance cure but without stopping the wet

conditions, so recurrence is always high [2].

Still many housewives do not take the advice of wear-

ing gloves and again will prevent healing of chronic par-

onychia [4].

Accordingly, the aim of present work is to do occlu-

sion of the dead space by Vaseline alone compared with

using antimicrobial agents like fucidic acid and nystatin

and to record the therapeutic response to these therapies.

2. Patients and Methods

This double blind comparative therapeutic trial on the

effectiveness of two drugs topically applied on the nail

folds (nystatin and fucidic acid) compared with Vaseline

on treatment of housewife chronic paronychia. This was

conducted in the Department of Dermatology and Vene-

reology-Baghdad Teaching Hospital, Baghdad, Iraq from

May 2010-May 2011.

Eighty female patients with house wife chronic par-

onychia were enrolled in this study. Inclusion criteria

included all patients with housewife chronic paronychia

who attended for therapy. The diagnosis of chronic par-

onychia was established according to the following crite-

ria: housewife patients, absence of cuticle associated

with swelling and erythema of proximal and lateral nail

folds, separation of dorsal and lateral nail folds from nail

plate. While, exclusion criteria as follow: acute par-

onychia, infections like tinea unguam, warts, and her-

petic whitlow. Also, dermatological diseases that can

cause chronic paronychia such as pemphigus vulgaris,

psoriasis, and lichen planus, connective tissue diseases

like systemic lupus erythematosus, discoid lupus erythe-

matosus, dermatomyositis, and scleroderma were ex-

cluded. Peripheral vascular disease like perniosis, Bur-

ger᾽s disease, Raynaud᾽s disease, patients with immuno-

suppressive conditions, bone deformities, diabetes melli-

tus, and conditions requiring systemic or topical use of

corticosteroids, calcineurin inhibitors, retinoids and pro-

tease inhibitors were not included.

A full history was taken from each patient regarding

name, age, gender, marital status, residence, social status,

job, number of children, using of gloves and washing

machine, right or left hand, baking, smoking. Also dura-

tion, number of fingers involved, and type of treatment

used before.

All patients were examined regarding right or left hand

involvement or both, number of nails involved, presence

of swelling, tenderness, and purulent discharge, presence

of nail changes as buckled nail plates, transverse ridging,

nail discoloration and associated onycholysis or dystro-

phy.

Formal consent was taken from each patient before

starting the trial of treatment after full explanation of

nature of disease, course, prognosis, complications, na-

ture of drug, method of application, duration of treatment

and follow up and the ethical approval was obtained from

Scientific Council of Dermatology and Venereology,

Iraqi Board for Medical Specializations.

Evaluation of the patients was done to re-evaluate the

disease score and report any side effects from treatment

clinically and by photograph during study period of 12

weeks.

All patients were photographed by a digital camera as

a baseline and then on 12 weeks, in the same place with

fixed illumination and distance by using a digital camera

(Sony: Cyber shoot with resolution 12 mega pixels).

The following scoring system of the chronic par-

onychia was invented:

1) Loss of cuticle score = 1

2) Separation of proximal nail fold from nail bed with

different grades and this was measured by orange

stick introduced under the nail folds:

a. Separation just score = 1

b. Separation 2 mm score = 2

c. Separation > 2 mm score = 3

3) Swollen nail fold:

a. Swollen just score = 1

b. Swollen red score = 2

c. Swollen tender score = 3

4) Secondary nail changes:

a. Ridging score = 1

b. Dystrophy score = 3

When patients had multiple fingers involvement, the

severely affected one was scored only and the others al-

though treated they were not counted within scoring.

The treatment protocol: Patients were divided into 3

groups:

Group A: using topical white petrolatum (Vaseline®)

manufactured by Anglo-Dutch Company Unilever.

Group B: using topical nystatin ointment in Vaseline

base (Mycodin®) is manufactured by The State Company

Open Access JCDSA

Treatment of Chronic Paronychia: A Double Blind Comparative Clinical Trial

Using Singly Vaseline, Nystatin and Fucidic Acid Ointment

Open Access JCDSA

252

for Drug Industries and Medical Appliances Ninavaha-

Iraq, under license of SDI Co.15 grams tube. Each gram

contains nystatin 100.000 I.U of the ointment.

Group C: using topical fucidic acid ointment in Vase-

line base (Fusibact™) manufactured by Jamjoom Pharma.

15 grams tube.

Each 100 gram of the ointment contains the active sub-

stance sodium fusidate, which corresponds to 2 gram

sodium fusidate.

The treatment was applied twice daily on the proximal

and lateral nail folds. Treatment duration was 12 weeks.

All patients were advised to avoid cuticle trimming, nail

biting, picking, trauma and also were encouraged to use

rubber gloves with inner cotton lining for household

tasks.

Statistical analysis was carried out using paired t-test

to compare differences before and after treatment in each

group. Chi–square test was used to check relations be-

tween results either recovery or no recovery. P value less

than 0.05 was considered significant. SPSS (statistical

package for social sciences) version 17 was used for the

analysis.

3. Results

Eighty housewife patients with chronic paronychia were

completed the study their ages ranged from 15 - 68 with

mean ± SD of 37.26 ± 11.06 years. The role of contrib-

uting factors showed that moisture; super hydration, de-

tergents and rough work played the highest role in dam-

aging the nail cuticle and nail folds in all patients. Dura-

tion of disease ranged from half year- 12 years with

mean± SD of 2.166 ± 2.66 years. Total numbers of 184

fingers involved in 3 groups. Number of finger involved

ranged from (1 - 8) with mean ± SD of 2 ± 9.61 fingers.

The nail changes in patients of chronic paronychia dem-

onstrated in (Table 1).

Patients in Group A were treated by White petrolatum

ointment; forty house wife patients were included in this

group, their ages ranged from 15 - 60 years with mean ±

SD of 36.37 ± 10.8 years. Married females were 32

(80%) patients. They had (0 - 8) children with mean of 4

children. Twenty seven (67.5%) patients were using

washing machine, while only 3 (7.5%) patients were us-

ing gloves. Twenty (50%) patients were baking regularly.

All of them were right handed 40 (100%). Duration of

disease ranged from less than 1 year - 12 years with

mean ± SD of 2.6 ± 3.44 years. Total number of 88 fin-

gers was involved.

Right hand alone was involved in 29 (72.5%), while

both right and left hands were involved in 11 (27.5%).

Number of finger involved ranged from (1 - 7) with

mean ± SD of 2 ± 1.55 finger. Seventeen (42.5%) pa-

tients with 1 finger involvement, 8 (20%) patients with 2

fingers, 8 (20%) patients with 3 fingers, 4 (10%) patients

with 4 fingers, 3 (7.5%) patients with 6 fingers. No any

side effect reported from treatment. Most commonly in-

volved finger in right hand was middle finger 22 (55%)

followed by thumb 19 (47.5%), ring finger 18 (45%),

index 13 (32.5%) with no little finger involvement.

While in left hand most common finger involved was

thumb 7 (17.5%), both middle and ring fingers 4 (10%)

and index only 1 (2.5%).

Patients in Group B were treated by nystatin ointment;

twenty house wife patients were included in this group,

their ages ranged from 19-55 years with mean ± SD of

37.40 ± 10.75 years. Married females were 18 (90%)

patients. They had (0 - 7) children with a mean of 3 chil-

dren. Twelve (60%) patients were using washing ma-

chine. Three (15%) patients were using gloves. Ten

(50%) patients were baking regularly.

All of them were right handed 20 (100%). Duration of

disease ranged from less than 1 year - 12 years with

Table 1. The nail changes in patients of chronic paronychia at presentation.

Group A (Vaseline) Group B (Nystatin ointment)Group C (Fucidic acid ointment)

No. % No. % No. %

Loss of cuticle 40 100 20 100 20 100

Nail fold swelling 40 100 20 100 20 100

Separation of nail fold from nail plate 40 100 20 100 20 100

Transverse ridging 39 95 20 100 20 100

Longitudinal ridging 8 20 2 10 2 10

Nail pitting 28 70 13 65 10 50

Onycholysis 8 20 1 5 2 10

Nail plate dystrophy 5 12.5 3 15 2 10

Color changes 34 85 17 85 15 75

Treatment of Chronic Paronychia: A Double Blind Comparative Clinical Trial

Using Singly Vaseline, Nystatin and Fucidic Acid Ointment

253

mean ± SD of 1.98 ± 2.74 years. Total number of 39 fin-

gers was involved. Number of finger involved ranged

from (1 - 8) with mean of ± SD of 2 ± 1.71 fingers, thir-

teen (65%) patients with 1 finger involvement, 2 (10%)

patients with 2 fingers, 3 (15%) patients with 3 fingers, 1

(5%) patient with 4 fingers, 1 (5%) patient with 8 fingers.

No any side effect reported from treatment. Right hand

alone was involved in 13 (65%), left hand was involved

in 2 (5%), while both right and left hands were involved

in 5 (25%). Most commonly involved finger in right

hand was thumb 11 (55%) followed by ring finger 7

(35%), middle finger 5 (25%), index 4 (20%), little fin-

ger only 1 (5%), while in left hand most common finger

involved was middle 4 (20%), followed by index 3

(15%), then both ring and thumb 2 (10%) for each one

while little finger was not involved.

Patients in Group C were treated by fucidic acid oint-

ment; twenty house wife patients were included in this

group, their ages ranged from 22 - 68 years with mean ±

SD of 38.90 ± 12.195 years. Married females were 19

(95%) patients; they had (0 - 8) children with a mean of 4

children.

Eleven (55%) patients were using washing machine.

One (5%) patient was using gloves. Nine (45%) patients

were baking regularly. All of them were right handed 20

(100%). Duration of disease ranged from less than 1 year

- 10 years with mean ± SD of 2.035 ± 2.178 years. Total

number of 57 fingers was involved.

Number of finger involved ranged from (1 - 6) with

mean of ± SD of 3 ± 1.576 fingers, four (20%) patients

with 1 finger involvement, 7 (35%) patients with 2 fin-

gers, 3 (15%) patients with 3 fingers, 3 (15%) patients

with 4 fingers, 1 (5%) patient with 5 fingers, 2 (10%)

patients with 6 fingers. No any side effect reported from

treatment. Right hand alone was involved in 12 (60%),

while both right and left hands were involved in 8 (40%).

Most commonly involved finger in right hand was thumb

16 (80%) followed by index and middle fingers 10 (50%)

for each finger, then ring finger 5 (25%), little finger

only 1 (5%), while in left hand most common finger in-

volved was thumb 6 (30%), followed by index 4 (20%),

then middle 3 (15%) lastly ring finger was 2 (10%).

Clinical Response

According to the present study results we can divide pa-

tients in each group into: patients with recovery and pa-

tient without recovery.

1. Recovery: either cured: re-growth of cuticle, no sepa-

ration of nail folds from nail bed, normal proximal

nail fold, nail plate grows normally or improved: ab-

sence of cuticle, nail folds just separated from nail

bed, normal proximal nail fold, nail plate grows nor-

mally (score = 0 - 2).

2. No recovery: either stable: absence of cuticle, nail

folds separated from nail bed > 2 mm, proximal nail

folds just swollen, abnormal nail plate (ridging, dys-

trophy) or worse: absence of cuticle, nail fold sepa-

rated from nail bed > 2 mm, proximal nail fold swol-

len tender, abnormal nail plate (ridging, dystrophy)

with purulent inflammation of the proximal nail fold

(score = 3 - 11).

There were highly statistically significant differences

in recovery of paronychia in all groups when we com-

pared the scoring before and after therapy after 3 months

of treatment (P ≤ 0000.1) (Table 2 and Figure 1).

When the three groups where compared between each

other, there was no significant statically difference in

recovery rate between them (P = 0.784) (Table 3).

4. Discussion

Chronic paronychia is an inflammatory dermatosis of the

nail folds, with secondary effects on the nail matrix; nail

growth and soft-tissue attachments [5].

The etiology of chronic paronychia is multifactorial in

origin [6]. Infection by multipule organism, especially-

yeasts (commonly Candida albicans) and intestinal bac-

Table 2. The recovery of chronic paronychia patients be-

fore and after therapy in the 3 groups.

Group Range

of score

Mean

of score

St.

dev. t-test P-value

A Before7 - 11 8.10 1.150

VaselineAfter0 - 11 3.65 2.627

10.779 <0.0001

B Before5 - 11 7.85 1.348

NystatinAfter0 - 10 3.60 2.945

6.514 <0.0001

C Before6 - 11 8.15 1.348

FucidinAfter0 - 8 3.70 2.452

5.973 <0.0001

Table 3. The clinical response to treatments in the 3 groups.

Group

Group A

(Vaseline)

Group B

(Nystatin)

Group C

(Fucidin)

No.% No. % No. %

Recovery rate 2665 13 65 12 60

No recovery rate 1435 7 35 8 40

Total 40100 20 100 20 100

Value Df P value

Chi-Square (x2) 0.487 2 0.784

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Treatment of Chronic Paronychia: A Double Blind Comparative Clinical Trial

Using Singly Vaseline, Nystatin and Fucidic Acid Ointment

254

(a)

(b)

(c)

Figure 1. Chronic paronychia in the right thumb in a

housewife before and after treatment by topical Vaseline. (a)

At presentation; (b) At 6 weeks after treatment; (c) At 12

weeks after treatment.

teria, is proposed to be a major etiologic factor, but re-

cent studies have established the pivotal role of irritants

and allergens in the development of chronic paronychia

[7].

Chronic paronychia is a major health problem among

Iraqi house wife dermatoses as it accounts for 33.3% of

the whole occupational housewife dermatoses [2].

It is well established that house wife work is the main

etiological factor in the etiopathogenesis of chronic par-

onychia where it works through the following factors: the

wet condition and the trauma of house work will cause

loss of nail cuticle followed by separation of proximal

and lateral nail folds this will allow water, detergents,

bacteria to enter under the nail folds followed inflamma-

tion leading to the main features of chronic paronychia

mainly swelling of the nail folds, nail dystrophy, this is

so called wet theory [2].

Sharquie et al. performed a study in 1990 on microbi-

ology of chronic paronychia in Iraqi housewives. [2] The

primary isolation from cultures on Sabouraud᾽s agar

showed Candida organisms in 93.3% of the cases, of

which 88.3% were Candida albicans, while the bacterial

isolates were mainly: Coliform in 33.3%, Pseudomnas

aeruginosa plus coliform in 26.6%, Proteus species plus

coliforms in 8.3%, Staphylococcus aureus 16.6%, and

other organisms as Diphtheroids, Streptococcus fecalis,

and Staphphylococcus albus [2]. And these findings were

supported by further studies [8].

But presence of these bacteria and candida might play

secondary role in the pathogenesis of paronychia [2]. So,

the therapy of chronic paronychia is mainly through pre-

vention of house work through wearing gloves. Still

many dermatologists use antibacterial and antifungal

therapy for long time to treat chronic paronychia but in

most of cases there is a failure of treatment [2]. So, the

aim of present work is the treatment of paronychia just

through using any ointment like Vaseline to block the

entrance of detergents and bacteria under the nail folds

and to the dead space under these folds. And this treat-

ment was compared with topical antifungal and antim-

icrobial agents.

The results of present study showed that using Vase-

line, nystatin or fucidic acid where highly statistically

significant effective in clearing paronychia (P ≤ 0.0001),

when these groups where compared with each other there

was no statistically difference (P = 0.784).

The group that used Vaseline showed the following

results: recovery rate was 26 (65%) patients, while there

was no recovery in 14 (35%) patients, while patients in

nystatin group showed recovery rate in 13 (65%) pa-

tients, while there was no recovery in 7 (35%) patients.

While, patients on fucidic acid ointment gave recovery

rate in 12 (60%) patients, while there was no recovery in

8 (40%) patients. Accordingly, the present study had

proved that occlusion of nail folds from wetting condi-

tion through using Vaseline or antimonilial ointment or

antibacterial ointment was enough to clear signs and

Open Access JCDSA

Treatment of Chronic Paronychia: A Double Blind Comparative Clinical Trial

Using Singly Vaseline, Nystatin and Fucidic Acid Ointment

Open Access JCDSA

255

symptoms of paronychia and even might prevent the re-

lapse of the disease through ointment. The present re-

search to the best of our knowledge is the first one that

has been carried out in the field of chronic paronychia.

5. Conclusion

In conclusion, treatment of paronychia by occlusive

therapy using Vaseline alone is enough to induce recov-

ery and clearance of housewife paronychia.

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