Yemisrach Argaw 5 14 2019
Yemisrach Argaw 5 14 2019
Yemisrach Argaw 5 14 2019
BY
YEMISRACH ARGAW
ADVISORS
April, 2019
Last but not least, I would like to thank the dermatology residents working in dermatology OPD
in ALERT HOSPITAL.
i
Contents
ACKNOWLEDGEMENT .................................................................................................................................... i
ABREVIATION ............................................................................................................................................... iv
Abstract ......................................................................................................................................................... v
1. INTRODUCTION ..................................................................................................................................... 1
1.1 Background ......................................................................................................................................... 1
1.2 Statement of the Problem .................................................................................................................. 2
1.3 Significance of the Study ..................................................................................................................... 3
2. LITRATUREREVIEW ................................................................................................................................ 4
3. OBJECTIVES ........................................................................................................................................... 9
3.1 General Objectives .............................................................................................................................. 9
3.2 Specific Objectives .............................................................................................................................. 9
4. METHODOLOGY ........................................................................................................................................ 9
4.1 Study design ........................................................................................................................................ 9
4.2 Study area and period ......................................................................................................................... 9
4.3 Source Population ............................................................................................................................. 10
4.4 Study Population ............................................................................................................................... 10
4.5 Eligibility ............................................................................................................................................ 10
4.5.1 Inclusion Criteria ........................................................................................................................ 10
4.5.2 Exclusion Criteria........................................................................................................................ 10
4.6 Sampling technique and Sample size ................................................................................................ 10
4.7 Variables............................................................................................................................................ 11
4.7.1 Dependent Variable ................................................................................................................... 11
4.7.2 Independent Variables ............................................................................................................... 11
4.8 Data Collection Instruments and procedure..................................................................................... 11
4.9 Data processing and analysis ............................................................................................................ 11
4.10 Data quality Assurance ................................................................................................................... 11
4.11 Ethical Consideration ...................................................................................................................... 11
4.12 Dissemination Plan.......................................................................................................................... 11
5. WORK PLAN......................................................................................................................................... 12
6. Budget Proposal .................................................................................................................................. 13
References .................................................................................................................................................. 14
ii
List of Table
Table 1 Comparison of efficacy at 12 weeks of treatment............................................................................ 7
Table 2: Work plan .................................................................................................................................... 12
Table 3: Stationary ...................................................................................................................................... 13
Table 4: Personal costs................................................................................................................................ 13
iii
ABREVIATION
ALERT All African Leprosy Rehabilitation and Training Center
MC MolluscumContagiosum
TCA TrichloroaceticAcid
GC Grigorian Calendar
iv
Abstract
Background
Objective
To compare the efficacy of 5% Potassium hydroxide (KOH) versus 10% KOH in the treatment
of MC.
Method
Project work plan and budget- The study proposal will be developed and approved from
March 2019 to April 2019. Data will be collected and analyzed till September 2019 and finally
submitted in October 2019. The total budget proposed for this project is 29,625.00 Ethiopian
birr.
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Research proposal 2011
1. INTRODUCTION
1.1 Background
MC was first described and later assigned its name by Bateman in the beginning of the
Nineteenth Century. In 1841, Henderson and Paterson described the intracytoplasmic inclusion
bodies now known as Molluscum or Henderson-Paterson bodies. In the early Twentieth Century,
Julinsberg, Wile and Kingery were able to extract filterable virus from lesions and show
transmissibility.[1]
MC is among the most common viral skin infections, occurring in approximately 2-8% of
children. MC is caused by Molluscum virus which belongs to the family Poxviridae subgenus
Molluscipox virus, which comprises 4 genetically subdivided but clinically indistinguishable MC
viral types.MC virus type I causes the majority of infection (76%-97%).In patients infected with
HIV however, MC virus-2 causes the majority of infection (60%).[1]
The disease is common, although the incidence in most areas is not reliably known. Infection
follows contact with infected persons,contaminatedobjects. The disease is rare under the age of
1 year, perhaps due to maternally transmitted immunity and a long incubation period.
Approximately 80% of the patients are younger than 8 years old, with equal sex distribution.[1]
In Iraq, in a study done in 1989 it has been found the incidence of MC among Iraq children
attending dermatovenereology unit to be 0.2% ,but nowadays, there is a dramatic increase in the
incidence of the infection between Iraq children (Sharquie personal observation 2008). The
prevalence within the HIV population is estimated to be 5-18% and the incidence and severity of
MC in acquired immune deficiency syndrome (AIDS) patients is inversely proportionate to the
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CD4 count. In AIDS patients with a CD4 count under 100/ml, the associated incidence of MC is
30%.
The incubation period is variously estimated at 14 days to 6 months. MC often presents with
extremely small pink, pearly or flesh colored papules, averaging 3-5 mm in diameter,
occasionally reaching sizes of up to 3 cm (“giant Molluscum”). As they enlarge, a dome-shaped,
opalescent morphology may become apparent. The lesion may have a central dell or umbilication
within which a white curd-like substance can be seen that can be expressed with pressure.[3]
Generally, MC can occur on any part of the body surface including face, trunk, extremities,
scalp, eyelid, lip, tongue, buccal mucosa, and the soles where the appearance is atypical. MC has
occurred in scars in tattoos apparently transmitted in the pigment.In addition, in about 10% of
lesions, a surrounding eczematous reaction is present (Molluscum dermatitis).The duration of
both the individual lesion and the attack is very variable and although most cases are self-
limiting within 6-9 months, some persist for 3 or 4 years.[3]
Three groups are primarily affected: young children, sexually active adults, and
immunosuppressed persons, especially those with HIV infection. In young children, the lesions
are usually generalized and numbers from a few to more than one hundred lesions tend to be on
the face, trunk and extremities. Genital lesions occurring as part of a wide distribution occur in
10% of childhood cases. When MC is restricted to the genital area in a child, the possibility of
sexual abuse must be considered.[4]
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It also helps to convince the patients to have the courage in using the medicines and observing
the result by referring the study. As there is no research done on this issue in Ethiopia, it can also
be used as a guideline and reference for further study on a broad way in the future.
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2. LITRATUREREVIEW
KOH is a strong alkali, which is known to digest proteins and lipids. It bears a keratolytic
property and known to penetrate deeply and destroy the skin. It has been used in various
concentrations, that is,2.5%, 5%, 10%, and 20%, for the treatment of MC.10% KOH has the dual
advantage of safety and efficacy.[9]
The current treatment modalities include physical destruction of the lesion by curettage,
cryosurgery or manual expression and topical application of caustic agents such as
trichloroacetic acid, cantharidin, silver nitrate etc. These therapeutic approaches have to be
undertaken in a hospital setup and are not well tolerated by children owing to substantial pain
and fear. In addition, these can also result in scarring and abscess formation. Topical application
of 10% KOH solution and 0.05% Tretinoin cream are two relatively painless modalities that
have been used with success in the treatment of MC.[10]
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were randomly divided into 3 groups.The Group I have given 10% KOH solution to be applied at
bed timeover molluscum lesions. The Group II have given 0.05% tretinoin cream to be applied at
bed time over lesions. The Group III applied TCA in OPD. The assessment of response and side
effects were performed weekly for 4 weeks. The results showed that the mean lesion count
decreased from 22.39 to 10.75 with tretinoin, from 20.79 to 4.31 with KOH and from 20.49 to
4.1 with TCA at the end of 4 weeks. They found complete clearance of lesions in 8 (44.44%)
patients with tretinoin, in 11 (50%) patients with 10% KOH and in 12(60%) with TCA. Minor
side effects were seen in 17(85%) patients on TCA, 16 (72.72%) patients on KOH and 10
(55.56%) patients on tretinoin. The results of this study suggest that all three agents i.e.0.05%
tretinoin cream, 10% KOH solution and TCA are equally effective in MC though TCA has a
faster onset of action. However, TCA solution is associated with a higher incidence of side
effects.And finally they reached at a conclusion that the KOH therapy has advantage of ease to
use in children &was also effective treatment. No scarring & pigmentation was seen in KOH
application. TCA has better results but has disadvantages of being not used at home and in
children. Procedure is also painful. Tretinoin has very low efficacy and disadvantage of
prolonged treatment.[10]
In another study done in the Department of Dermatology, Yansan Pusan National University
Hospital, School of Medicine, Korea, out of 30 patients, 3 patients were non-compliant and did
not follow-up. Fourteen patients in the imiquimod group and 13 patients in the KOH group
completed the study.Complete clearance of lesions seen in 8 (57%) out of 14 patients with
imiquimod, of which 7 patients were cleared of lesions by 4 weeks, and 1 by 8 weeks. However,
2 patients showed no responses until week 12. Total clearance of lesions observed in 10 (77%)
out of 13 patients with KOH. Out of these 10 patients, 6 were cleared of lesions by 4 weeks and
the other 4 patients by 8 weeks. However, 1 patient showed no response until week 12.[10].In
conclusion, both 10% KOH solution and 5% imiquimod cream are effective and safe treatments
of MC. On top of that, they have an advantage over curettage because they are less traumatic,
less painful, and easier to administer (at home). These characteristics make them particularly
helpful in thetreatment of MC in children. Considering the low cost and faster clearance of
lesions using KOH solution, it could be a better option in the treatment of MC.[10]
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In a study done to comparethe efficacy of 2 different concentrations ofKOH (2.5% and 5%),out
of 29 patients recruited in the study 25 completed it; 13 in 2.5% group and 12 in 5% group. 11
(44%) of the patients had lesional clearance at the end of the study. 8 of these patients were in
the 5% treatment group and 3 were in the 2.5% KOH group. This difference was statistically
significant (p < 0.047). There were no statistical differences between the two groups with respect
to side-effects (p = 0.682).[11]
Al Sudanyetal have compared 10% KOH with 25% podophyllin solution. They found 64% of
their patients were cleared of MC lesions at the end of the study.[11]
In a more complicated research done by Prof. Dr. Azar H. Maluki, Iraq,comparingtreatment of
MC by Potassium Hydroxide solution 20% with and without Pricking and by pricking alone. The
patients had been equally divided into 3 groups; each of them consists of 30 patients.[12]
Thirty patients, 10 of them defaulted for unknown reason and other 2 patients developed side
effects. The remaining 18 patients were treated by topically applied 20% KOH. During the
treatment period 2 (11%) patients were completely cured after the first week of treatment, 5
(27%) patients required another week and 10 (54%) patients healed after the fourth week. one
(6%) patient did not respond completely.[12]
Thirty patients, 7 defaulted for unknown reasons and 23 patients were treated by 20% KOH with
pricking. After one session of treatment 1(4%) patient was completely cured, 11 (47%) patients
needed another week of treatment and 8 (35%) patients were cured at the end of the fourth week.
At the end of the treatment period 3 (13%) patients were still having lesions.[12]
Thirty patients, 14 defaulted for unknown reasons and 16 patients were treated by pricking
only.After one session none of the patients was cured completely, 3 (18%) patients required two
sessions and 9 (56%) patients needed another session to accomplish complete healing, while 4
(25%) patients still have lesions.[12]
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As a conclusion this study using topical 20% KOH daily, 20% KOH with pricking and pricking
only once weekly showed cure rates of 94%, 86% and 75% respectively after 4weeks of
treatment, the reported side effects were mild pain due to pricking, mild burning sensation and
transient erythema and secondary bacterial infection which required only topical antibiotic.
Scaring and relapse were not reported in all of the patients.
Patients were divided in to 2 groups. Group A treated with 5% KOH solution and group B was
treated with 10% KOH solution. Patients were advised to apply KOH preparation with cotton-
tipped applicator on every lesion once daily for two weeks or till the signs of inflammation i.e.
erythema became evident. The same observer carried out the assessment of therapeutic response
at week 2, 4, 8 and 12 by counting MC lesions. Twenty patients were included in both groups i.e.
5% KOH (group A) and 10% KOH (group B). The two groups were well-matched in terms of
pre-treatment clinical parameters. Out of 20 patients in group A (treated with 5% KOH solution),
16 completed the study whereas in group B (treated with 10% KOH), 17 completed the study.
The rest were lost to follow-up due to non-treatment reasons.[13]
At final follow-up i.e. 12 weeks, the reduction in the number of lesions is compared in group A
(5% KOH), none of the patients showed complete clearance, however, partial clearance was seen
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in 4 (25%) patients and the insignificant improvement occurred in the rest. In contrast, in group
B (10% KOH) complete clearance of lesions was noticed in 7 (41.2%) patients whereas 10
(58.8%) partial remission. [14]
The results showed that 10% KOH solution is significantly more effective than 5% KOH
solution in the treatment ofMC. By the 12 week of study, complete or partial remission was seen
in all (100%) patients whereas only 4 (25%) patients treated with 5% KOH solution showed
partial remission.[14]
Romiti et al. pioneered the use of KOH in the treatment of MC. They noticed complete clinical
cure in 32 of 35 patients after a mean treatment period of 30 days with 10% KOH solution twice
daily. [15]
Short et al. (2006) treated 10 patients each with 10% KOH or placebo and found 70% and 20%
clearance, respectively. The average time to clearance was 54 days.[15]
Can et al. treated 40 children with MC with 10% KOH solution twice daily. They noted complete
clearance of lesions in 37 (92.5%) patients after a mean period of four weeks. The 10% KOH
solution showed efficacy similar to that of cryotherapy,salicylic acid and lactic acid
combination,andimiquimod.[15]
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3. OBJECTIVES
3.1 General Objectives
To compare the efficacy of 5% KOH versus 10% KOH in the treatment of MC
4. METHODOLOGY
4.1 Study design
Hospital based comparative study will be conducted at dermatology OPD of ALERT hospital.
ALERT’s activities focus on rehabilitation of leprosy patients, training programs for leprosy
personnel from around the world and leprosy control. And currently provides a wide range of
services in various departments including dermatovenereology, emergency, gynecology and
obstetrics, pediatrics,ophthalmology, ART, orthopedics, plastic surgery etc…
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4.5 Eligibility
4.5.1 Inclusion Criteria
New clinically diagnosed MC patients with lesion duration of more than two months presenting
at ALERT hospital dermatology OPD during the study period.
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4.7 Variables
4.7.1 Dependent Variable
Treatment efficacy of MC treated with 5% KOH versus 10% KOH.
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5. WORK PLAN
Table 2: Work plan
Research proposal
development
Ethical clearance
Data Collection
Data entry
Data analysis
Research paper
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6. Budget Proposal
Table 3: Stationary
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References
1. Van der Wouden JC, van der Sande R, van Suijlekom‑Smit LW, Berger M, Butler CC,
Koning S. Interventions for cutaneous Molluscumcontagiosum.
2. Myskowsky PL; Molluscumcontagiosum. Arch Dermatol., 1997; 133: 1039-1041.
3. Hanson D, Diven DG; Molluscumcontagiosum. Dermatol Online J., 2003.
4. Baverl C, Feller G, Goerdt S; Experience in treating molluscum contagious in children
with imiquimod5% cream. Br J Dermatol., 2003;149(6):25-29.
5. Romiti R, Ribeiro AP, Grinblat BM, Rivitti EA, Romiti N. Treatment of
Molluscumcontagiosum with potassium hydroxide: A clinical approach in 35 children.
PediatrDermatol 1999.
6. Lu Q, Zeltzer L, Tsao J. Multiethnic differences in responses to laboratory pain stimuli
among children. Health Psychol 2013.
7. Mathes EF, Frieden IJ. Treatment of Molluscumcontagiosum with cantharidin: A
practical approach. Pediatr Ann 2010.
8. Dohil MA, Lin P, Lee J, Lucky AW, Paller AS, Eichenfield LF. The epidemiology of
Molluscumcontagiosum in children. J Am AcadDermatol 2006.
9. Romiti R, Ribeiro AP, Romiti N. Evaluation of the effectiveness of 5% potassium
hydroxide for the treatment of Molluscumcontagiosum. PediatrDermatol 2000.
10. Metkar A, Pande S, Khopkar U. An open, nonrandomized, comparative study of
imiquimod 5% cream versus 10% potassium hydroxide solution in the treatment of
Molluscumcontagiosum. Indian J DermatolVenereolLeprol 2008.
11. Seo SH, Chin HW, Jeong DW, Sung H. An open randomized, comparative clinical and
histological study of imiquimod 5% cream versus 10% potassium. Ann Dermatol. 2010;
22(2): p. 156-162.
12. 5th annual middle east congress on clinical nutrition intercontinental city stars march
24,2016 ,Cairo,Egypt.
13. Metkar A, Pande S, Khopkar U. An open, nonrandomized, comparative study of
imiquimod 5% cream versus 10% potassium hydroxide solution in the treatment of
molluscumcontagiosum. Indian J DermatolVenereolLeprol. 2008.
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14. Seo SH, Chin HW, Jeong DW, Sung HW. An open, randomized, comparative clinical
and histological study of imiquimod 5% cream versus 10% potassium hydroxide solution
in the treatment of molluscumcontagiosum. Ann Dermatol. 2010.
15. Köse O, Özmen I, Arca E. An open, comparative study of 10% potassium hydroxide
solution versus salicylic and lactic acid combination in the treatment of
molluscumcontagiosum in children. J Dermatolog Treat. 2013.
MRN…………………………………
1.Age …………………………………………
2.sex……………………….
3. Geographic area
Urban
Rural
4. Socio-Economic Status
Upper
Middle
Lower
5. Occupation
Students
Others
6. Duration of disease
7. No of Lesions
8.Site of lesion-Face
-Trunk
-Extremities
9.Past History
Present
Absent
10.Family History
Present
Absent
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