| CTRI Number |
CTRI/2020/12/030133 [Registered on: 30/12/2020] Trial Registered Prospectively |
| Last Modified On: |
29/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A CLINICAL STUDY OF PITYRIASIS VERSICOLOR, A FUNGAL INFECTION WITH SKIN MICROSCOPY (DERMOSCOPY) AND FUNGAL CULTURE, I.E, ARTIFICIAL FUNGUS GROWING TECHNIQUE. |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF PITYRIASIS VERSICOLOR WITH DERMOSCOPY AND FUNGAL CULTURE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Anusha Dsouza |
| Designation |
Post graduate (MD)-Dermatology, Venereology & Leprosy |
| Affiliation |
Father Muller Medical College Hospital |
| Address |
G3, Vishwas Royal, Mission Compound, Falnir, Mangalore
Fr Mullers, Kankanady, Mangalore -575002
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8722238590 |
| Fax |
|
| Email |
anadsza@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rochelle Cheryl Monteiro |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College Hospital |
| Address |
Dept. of Dermatology, Venereology & Leprosy
Fr. Muller Medical College
Kankanady, Mangalore
Fr Mullers Road, Kankanady, Mangalore-575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9739315324 |
| Fax |
08242436352 |
| Email |
rochelle.cheryl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivashankara A R |
| Designation |
Member secretary |
| Affiliation |
Father Muller Medical College Institutional Ethics Committee |
| Address |
Father Muller Medical College Institutional Ethics Committee,
Kankanady, MANGALORE
Fr Mullers, Kankanady, Mangalore -575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9880146133 |
| Fax |
|
| Email |
arshiva72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funding/ IADVL Grant if obtained |
|
|
Primary Sponsor
|
| Name |
IADVL |
| Address |
IADVL National Headquarters
314-315,
3rd Floor KM Trade Tower,
H 3, Sector 14,
Kaushambi, Ghaziabad,
Uttar Pradesh. 201010 |
| Type of Sponsor |
Other [Indian Association of Dermatologists, Venereologists and Leprologists] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rochelle Cheryl Monteiro |
Father Muller Medical College |
Department of dermatology, Venereology & leprosy,Father Mullers Road, Kankanady, Mangalore-575002
Dakshina Kannada
KARNATAKA |
9739315324
0824-2436352
rochelle.cheryl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Medical College Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients (includes all age groups) clinically diagnosed with Pityriasis versicolor showing positivity on KOH mount. |
|
| ExclusionCriteria |
| Details |
Patients who are on oral or topical anti-fungal treatment. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The reference data obtained in the study can be used to better understand the clinical and mycological pattern of Malassezia in our geographical area. |
Better understanding the disease causative agent and its clinical forms and distributions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the requirements for growth of causative agent |
To study the additional factors which help in pathogenecity of disease |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
yet to be |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pityriasis versicolor is an asymptomatic,
superficial, chronic fungal infection caused by Malassezia species, affecting the stratum corneum layer of skin. The caustaive agent Malassezia
comprises of a group of superficial dimorphic fungi occurring as normal skin
flora on the human body. Though generally associated with very mild superficial
infection, it is emerging as an opportunistic fungal pathogen in
immunocompromised patients. Even though there is disparity in geographical
distribution of different species, not much data is available from our country.
Hence this study is undertaken to know the clinical patterns with respect to
morphology and distribution, associated risk factors and to know the
distribution of different Malassezia
species in Piytriasis versicolor infection. This study will include 115 patients of all age groups. Detailed history, Clinical examination along with woods lamp examination will be done. Following which KOH mount and Scrapings for fungal culture will be taken using aseptic precautions. Fungal culture will be left to grow for 21 days in optimum temperature and growth will be recorded following which speciation will be done. Results will be analyzed using appropriate statistical methods. |